FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.


February 24, 1999                                   99-08

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________
PRODUCT
Nino's Frozen Gnocchi, in 16 ounce plastic bags. Recall #F-182-9.

CODE
All product on the market at the time of the recall.

MANUFACTURER
Nino's Market and Fresh Pasta, Inc., Philadelphia, Pennsylvania.

RECALLED BY
Manufacturer, by telephone on January 8, 1999, by press release on January 12, 1999, and by letter mailed on January 13, 1999. Firm-initiated recall complete.

DISTRIBUTION
Pennsylvania, Delaware, New Jersey.

QUANTITY
264 bags were distributed.

REASON
Product contains undeclared eggs.

________
PRODUCT

E. Wedel brand chocolate bars:
a) Milk Chocolate (Czekolada Mleczna) 180g and 100g 
b) Milk Chocolate with Hazelnuts (Luksusowa z Orzechami
Laskowymi) 180g
c) Plain Chocolate (Czekolada Deserowa) 100g
d) Bitter-Sweet Chocolate (Jedyna) 100g
e) Milk Chocolate with Orange Filling (Mleczna z Nadzieniem
Pomaranczowym) 100g.  Recall #F-183/187-9.

CODE
All product on the market at the time of the recall.

MANUFACTURER
E. Wedel S.A., Warsaw, Poland.

RECALLED BY
European Continental Imports, Inc., Hamtramck, Michigan, by press release on November 25, 1998, followed by visits to be completed by December 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
Southeast Michigan.

QUANTITY

Firm estimates approximately 25 dozen boxes of various variety.

REASON
Products may be contaminated with peanut residue from other products produced at the manufacturer.

________
PRODUCT

Almond Butter, Cashew Butter, Hazelnut Butter, Peanut Butter,
Tahini, Roasted and Raw Nuts as follows:
a)  The following NUT BUTTERS:
Almond Butter, Smooth and Crunchy varieties, sold under the
following labels and sizes:
     "Once Again Nut Butter", 9 oz. and 16 oz. glass, 9 lb. and 
     35 lb. bulk pails
     "Tree of Life", 16 oz. glass
     "Nature Food Centres", 16 oz. glass
     "Whole Foods", 16 oz. glass
     "Bread & Circus", 16 oz. glass
     "Woodstock", 16 oz. glass 
Cashew Butter, smooth variety, sold under the following labels
and sizes:
     "Once Again Nut Butter", 9 oz. and 16 oz. glass, 9 lb. and
      35 lb. bulk pails
     "Tree of Life", 16 oz. glass
     "Woodstock", 16 oz. glass 
     "Nature Food Centres", 16 oz. glass
     "Whole Foods", 16 oz. glass
     "Bread & Circus", 16 oz. glass
Hazelnut Butter, smooth variety, sold under the following label
and sizes:
     "Once Again Nut Butter", 9 oz. and 16 oz. glass, 9 lb. bulk
     pails
Peanut Butter, smooth and crunchy, and ALL varieties including 
unblanched, organic, salted, unsalted, low sodium, no sodium,
under the following labels and sizes:
     "Once Again Nut Butter", 16 oz., 500 g, and  255 g glass, 9
     lb. and 35 lb. bulk pails.  Some product with dual
     declaration and one  label with Japanese labeling.
     "Bread & Circus", 16 oz. glass
     "Woodstock", 16 oz. glass and 35 lb. pails
     "Tree of Life", 16 oz. glass
     "Whole Foods", 16 oz. glass   
Tahini, regular and organic varieties, under the following
labels and sizes:
     "Once Again Nut Butter", 16 oz. glass and 9 lb. and 35 lb.
     bulk pails
     "Whole Foods", 16 oz. glass
     "Bread & Circus", 16 oz. glass
     "Nature Food Centres", 16 oz. glass
     "Woodstock", 16 oz. glass 
     "Tree of Life", 16 oz. glass
b)  The following roasted and raw nuts, sold under the "Once
Again Nut Butter" label, in 10 lb. and 25 lb.  boxes.  Valencia
Peanuts and Organic Cashews are also sold in one pound bags.
     Almonds
     Cashews  
     Peanuts (blanched) 
     Peanuts (Spanish) 
     Peanuts (organic Valencia) 
     Sesame seeds (organic).  Recall #F-188/198-9.

CODE
All lots without the corrective sticker ingredient declaration statement "MAY CONTAIN TRACE AMOUNTS OF OTHER NUTS, PEANUTS, AND SEEDS".

MANUFACTURER
Once Again Nut Butter, Inc., Nunda, New York.

RECALLED BY
Manufacturer, by press releases December 12, 1998, and December 13, 1998, followed by letter dated December 21, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Canada, Japan.

QUANTITY

Estimated quantities of each nut butter shipped:
     Almond - 400,000 lbs.
     Cashews - 135,000 lbs.
     Hazelnut - 8,375 lbs.
     Peanut Butter - 540,000 lbs.
     Sesame (Tahini) - 319,000 lbs.
Estimated quantities of roasted and raw nuts and seeds shipped:
     Cashews - 19,600 lbs.
     Almonds - 8,800 lbs.
     Peanuts (blanched, Spanish and organic Valencia) - 17,520
     lbs
     Sesame Seeds - 5,400 lbs.

REASON
The products may be contaminated with peanuts or tree nuts or residues of peanuts or tree nuts which are not declared on the products' labels.

________
PRODUCT

Various Salads and Slaws, packaged in in 5, 10, and 30 pound bulk
containers:
a) Menu Maker Tuna Fish Salad with Albacore
b) Harold Food Co. Tuna Fish Salad
c) Harold Food Co. Special Slaw
d) Harold Food Co. Cream Slaw.  Recall #F-199/202-9.

CODE
All products on the market at the time of the recall.

MANUFACTURER
Harold Food Company, Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letter on or about October 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
South Carolina, North Carolina, Ohio, Georgia.

QUANTITY

Firm estimates none remains on the market.

REASON
Products contain undeclared eggs.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________
PRODUCT

Various Salads, Spreads, and Slaws, packed in 5, 10, and 30 pound
bulk containers:
a) Harold Food Co. Carrot, Raisin, and Pineapple Salad
b) Harold Food Co. Special Pimento Cheese Spread
c) Harold Food Co. Garden Pasta Salad
d) Harold Food Co. Shredded Slaw.  Recall #F-203/206-9.

CODE
All products on market at time of recall.

MANUFACTURER
Harold Food Company, Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letter on or about October 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
South Carolina, North Carolina, Ohio, Georgia.

QUANTITY

Firm estimates none remains on the market.

REASON
The products' labels do not declare the ingredients of mayonnaise.

RECALLS AND FIELD CORRECTIONS: FOOD -- CLASS III

________
PRODUCT
Harold Food Co. Macaroni Salad packed in 5 and 10 pound bulk containers. Recall #F-207-9. Harold Food Company, Charlotte, North Carolina.

CODE
All product on market at time of recall.

MANUFACTURER
Harold Food Company, Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letter on or about October 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
South Carolina, North Carolina, Ohio, Georgia.

QUANTITY

Firm estimates none remains on the market.

REASON
The product's label does not declare the ingredients of salad dressing.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

________
PRODUCT
a) Revivarant Liquid, (2(3H)-Furanone), OTC, in 32 fluid ounce bottles; b) Revivarant G powder, (2(3H)-Furanone), OTC, in 200 gram bottles. Recall #D-116/117-9.

CODE
All lot numbers.

MANUFACTURER
Philips Pharmatech Labs, Inc., Largo, Florida.

RECALLED BY
Trimfast Group, Inc., Tampa, Florida, by fax and by mail on January 15, 1999. Firm-initiated recall ongoing. See also FDA talk paper T99-5, January 21, 1999.

DISTRIBUTION
Nationwide.

QUANTITY

a) 47,000 bottles; b) 4,500 bottles were distributed.

REASON
Products are unapproved new drugs.

________
PRODUCT
Gamma-G Night Time Formula powder, (2(3H)-Furanone), OTC, labeled as a nutritional supplement for oral use to induce sleep, in 200 gram bottles. Recall #D-118-9.

CODE
All lot numbers.

MANUFACTURER
Undetermined.

RECALLED BY
Conan Corporation, doing business as Castlewood Nutritional Services, Jefferson, Ohio (distributor), by telephone beginning on January 20, 1999, followed by fax on January 22, 1999. Firm-initiated recall ongoing. See also FDA talk paper T99-05, January 21, 1999.

DISTRIBUTION
Texas, North Carolina, Florida.

QUANTITY

Approximately 3,500 bottles were distributed.

REASON
Product is an unapproved new drug.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

________
PRODUCT
Oxygen, USP, compressed in high pressure cylinders (aluminum and steel), sizes D, E, and M6. Recall #D-099-9.

CODE
All lot numbers.

MANUFACTURER
Home Therapy Equipment Inc., Round Lake, New York.

RECALLED BY
Manufacturer, by visit beginning December 31, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New York and Massachusetts.

QUANTITY

Approximately 600 cylinders remained on market at time of recall initiation.

REASON
Incorrect equipment calibration for finished product assay.

________
PRODUCT
Oxygen USP, Compressed, in size D and E high pressure cylinders. Recall #D-108-9.

CODE
Lot numbers: 000A639, 000A640, 000A641, 000A686, 000A687, 000A691, 000A695.

MANUFACTURER
Virginia Medical & Respiratory Equipment, Inc., Grundy, Virginia.

RECALLED BY
Manufacturer, by visit to be completed within 24 hours. Firm-initiated recall complete.

DISTRIBUTION
Virginia and Kentucky.

QUANTITY

Firm estimated that 17 cylinders remained on market at time of recall initiation.

REASON
Current good manufacturing practice deviations including; failure to perform/and or document purity testing, equipment calibration, and temperature/pressure checks.

________
PRODUCT
a) Oxygen, USP, Compressed, "H", "E", "T" and "M" high pressure cylinders; b) Oxygen, USP, Refrigerated Liquid, in dewars (5010). Recall #D-111/112-9.

CODE
a) All lot codes manufactured on 6/2/98 through 1/7/99, ranging in sequence from 20F02H to 20A07I; b) All lot codes manufactured on 6/2/98 through 1/7/99, ranging in sequence from 20F02H to 20A07I.

MANUFACTURER
DeLille Oxygen Company, Zanesville, Ohio.

RECALLED BY
Manufacturer, initially on January 11, 1999, and by letter on January 29, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Ohio.

QUANTITY

Undetermined.

REASON
Current good manufacturing practice deviations; including lack of assay/potency equipment calibrations, production records missing, and incorrect expiration dating.

________
PRODUCT
Rowasa Suppository-rectal (Mesalamine), 500 mg, in packages of 2 (physician sample), 12, & 24, rectal suppository for the treatment of active ulcerative proctitis. Recall #D-113-9.

CODE
Lot numbers: 88787, 89030, 88860, 88788, 89029, 89028, 89027, 88859, 88785, 88786.

MANUFACTURER
G&W Laboratories, Plainfield, New York (contract manufacturer).

RECALLED BY
Solvay Pharmaceuticals, Inc., Marietta, Georgia, by letter dated December 4, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

186,602 units were distributed.

REASON
Product failed dissolution testing (stability).

________
PRODUCT
Creomulsion Pediatric Syrup (Dextromethorphan Hydrobromide USP 15mg/15mL, Pseudoephedrine Hydrochloride USP 30mg/15mL, Chlorpheniramine Maleate USP 2mg/15mL), OTC used for the treatment of coughs, colds, and allergies, in 4 fluid ounce bottles. Recall #D-114-9.

CODE
Lot #0Z4 EXP 11/01.

MANUFACTURER
Summit Industries, Marietta, Georgia.

RECALLED BY
Manufacturer, by telephone on December 21, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Tennessee.

QUANTITY

34 cases (12 bottles per case) were distributed.

REASON
Product exceeded microbial specification (Staph warneri).

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________
PRODUCT
Hydroxyzine Hydrochloride Syrup, USP (10 mg/5mL) in 16 ounce and 1 gallon bottles, used for symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested, under the Alpharma and Barre labels. Recall #D-098-9.

CODE

Lot No.   NDC No.       Size   Exp Date   Label
RP7873   0472-0771-16   16 oz  4/99       Barre
RP7873   0472-0771-28   Gallon 4/99       Barre
RC8101   0472-0771-16   16oz   4/99       Alpharma
RD8308   0472-0771-16   16oz   6/99       Alpharma
RD8308   0472-0771-28   Gallon 6/99       Barre.

MANUFACTURER
Alpharma, U.S. Pharmaceutical Division, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter on or about December 21, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

104,780 units were distributed.

REASON
Potency failure at stability testing.

________
PRODUCT

a) TAC-3  Injectable Suspension,(Triamcinolone Acetonide), 
3 mg/mL, Rx in 5 mL vials, (Parnell)
NDC   0023-0218-05   (Allergan Pharmaceuticals)
NDC   50930-218-05   (Parnell Pharmaceuticals);
b) Triamcinolone Acetonide Injectable Suspension, USP, 40 mg/mL ,
Rx in 5 mL and 1mL vials, 
NDC   0402-0204-05   (Steris Laboratories)
NDC   0364-6728-53   (Schein Pharmaceuticals)
NDC   0456-0781-05   (Forest Pharmaceuticals)
NDC   66467-9810-8   (Darby (Carlisle))
NDC   0182-1141-62   (Zenith Goldline Laboratories)
DIN#  02219271       (Schein Canada)
NDC   0677-0600-20   (United Research Laboratories)
NDC   55553-204-05   (Clint Pharmaceuticals)
NDC   25332-0101-2   (Legere Pharmaceuticals)
NDC   0536-9810-65   (Rugby Laboratories)
NDC   0839-6287-25   (Moore Medical)
NDC   53614-204-05   (Besse Medical)
NDC   52637-040-05   (AF Hauser)
NDC   11001-204-05   (San Jose Surgical Supply)
NDC   54171-204-05   (Robar)
NDC   52384-006-05   (Teregen Labs)
NDC   0904-0886-05   (Major Pharmaceutical)
NDC   0402-0204-01   (Steris Laboratories)
NDC   0364-6728-46   (Schein Pharmaceuticals)
NDC   0182-1141-85   (Zenith Goldline Laboratories)
DIN#   02219271      (Schein Canada)
NDC   99012-204-01   (RW Enterprises);
c) Prednisolone Acetate Injectable Suspension, USP, (sterile), 50
mg/mL in 10 mL and 30 mL vials, Rx,
NDC   0402-0249-30   (Steris Laboratories)
NDC   0364-6627-56   (Schein Pharmaceutical)
NDC   66467-6405-3   (Darby Group (Carlisle)
NDC   0182-0939-66   (Zenith Goldline Laboratories)
NDC   0402-0249-10   (Steris)
NDC   0364-6627-54   (Schein Pharmaceutical)
NDC   0456-0924-10   (Forest Pharmaceuticals);
d) Hydrocortisone Acetate Injectable Suspension,(sterile), 25
mg/mL, Rx in 10 mL vials
NDC   0402-0051-10   (Steris Laboratories)
NDC   0364-6624-54   (Schein Laboratories)
NDC   0067-0278-21   (United Research Laboratories)
NDC   66467-1200-1   (Darby (Carlisle);
e) Estrone Injectable Suspension, USP, (sterile) 5 mg/mL, Rx in
10 mL bottles
NDC   0402-0041-10   (Steris Laboratories)
NDC   0364-6601-54   (Schein Pharmaceutical)
NDC   57699-041-10   (A &G Pharmaceutical)
NDC   0677-0274-21   (United Research Laboratories)
NDC   0839-5585-30   (Moore Medical)
NDC   66467-5602-1   (Darby (Carlisle)
NDC   55553-041-10   (Clint Pharmaceuticals)
NDC   0314-0644-70   (Hyrex Pharmaceuticals)
f) Dalalone D.P.  Injectable Suspension  (Dexamethasone Acetate
Suspension), 16 mg/mL, Rx in 1 mL vials, NDC  0456-1097-41
(Forest Pharmaceuticals).  Recall #D-100/105-9.

CODE

Lot numbers:  a) 96B600 and 97E500; b) 96M880, 96N020, 98A331,
98B271, 98B701, 98C200, 98C371, 98C560, 98C721, 98D091, 98D210,
98D310, 98D470, 97D830, 97D831, 97J340, 97K670, 97F830, 97K160;
c) 96B670, 96E260, 96L540, 96M640, 96M630; d) 96C120, 96L140,
96N540; e) 96C040, 96E730, 96H400, 97A990, 97D610, 97E980, 97K990
f)97B740.

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona

RECALLED BY
Manufacturer, by letter on December 10, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY

Dexamethasone Acetate Suspension, 16 mg/mL, 1ml
37,400  - Distributed
Estrone Suspension, 5 mg/mL, 10ml
250,161 - Distributed
Hydrocortisone Acetate Suspension, 25mg/mL, 10ml
47,976  - Distributed
Prednisolone Acetate Suspension, 50 mg/mL, 10ml
16,984  - Distributed
Prednisolone Acetate Suspension, 50 mg/mL, 30ml
48,588  - Distributed
Triamcinolone Acetonide Suspension, 40 mg/mL, 1 mL
465,557 - Distributed
Triamcinolone Acetonide Suspension, 40 mg/mL, 5 mL
700,646  - Distributed
Triamcinolone Acetonide Suspension, 3 mg/mL, 5 mL
39,634  - Distributed.

REASON
Products lack valid resuspendability data.

________
PRODUCT
Thiothixene Hydrochloride Oral Solution, USP, 5 mg/mL, in 30 and 120 mL bottles, Rx, used for the management of manifestations of psychotic disorders, under the Alpharma and Barre labels. NDC numbers: Recall #D-106-9.

CODE
Lot numbers: RB7111 EXP 8/99, RD7284 EXP 8/99, RD8352 EXP 6/00.

MANUFACTURER
Alpharma, U.S. Pharmaceutical Division, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter on or about December 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

37,212 units were distributed.

REASON
Product exhibited cloudiness, precipitation, and/or crystallization. Product also failed assay for alcohol Content (subpotent).

________
PRODUCT
Desonide cream, 0.05%, topically administered (external only/not for ophthalmic use), in 15 and 60 gram tubes, Rx item indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. No brand name, generic name desonide only, under the Taro and Zenith Goldline labels. Recall #D-107-9.

CODE
Lot numbers 7E237 and 7E239. EXP date for both lots is 5/2000.

MANUFACTURER
Taro Pharmaceuticals, Inc., Bramalea, Ontario, Canada.

RECALLED BY
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, New York, by letter on January 19, 1999, followed by telephone on January 21, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

Lot 7E237 - 4,827/60 gram and 6,443/15 gram tubes shipped. Lot 7E239 - 6,510/60 gram tubes shipped The firm estimates no product remains in marketplace.

REASON
Product exceeded ANDA specification for degradant level (18 month stability.

________
PRODUCT
Periactin Syrup (Cyproheptadine HCL), USP, 2mg/5mL, in 473 mL bottles, Rx antihistamine. Recall #D-110-9.

CODE
Lot #A0296 EXP 5/99.

MANUFACTURER
Merck & Company, Inc., West Point, Pennsylvania.

RECALLED BY
Manufacturer, by letter sent on November 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

9,984 bottles were distributed.

REASON
Product failed pH specification (stability).

________
PRODUCT
Loperamide 2 mg. Tablets in 6, 12, 18 and 24 count blister cards under the following labels: Family Pharmacy, Arbor, Market Basket, medic, Family Independent, Grand Union, Goldline, Brook's, Freds, Fedco, Duane Reade, Hills, Happy Harry's, Quality Choice, Pathmark, MS, Kerr, Rite Aid, Shopko, Select, K & B, Smart Choice, Ames, FDC, REX, RMC, First Choice, and Kinney's. Recall #D-115-9.

CODE

7027851, 7027852, 7027853, 7027854, 7027855, 7027585,
7027856, 7027859, 7027857, 7027858, 7027860, 7027861, 7027862,
7027863, 7027864, 7027865, 7027866, 7027867, 7027868, 7027869,
7030557, 7038535, 7038536, 7038538, 7038540, 7038542, 7038543,
7038544, 7038545, 7038546, 7038547, 7038548, 7038549, 7038550,
7038552, 7038553, 7038555, 7038554, 7038556, 7038558, 7038713,
7038714, 7038829, 7038831, 7038832, 7038833, 7038834, 7038835,
7038836, 7038838, 7038839, 7038888, 7040076, 7040077, 7040078,
7040079, 7040236, 7049303, 7049304, 7049305, 7049306, 7049332,
7049526, 7049527, 7049528, 7049529, 7049530, 7049531, 7049533,
7049695, 7050616, 7050619, 7050620, 7050621, 7050623, 7050633,
7050656, 7050658, 7050689, 7050690, 7050691, 7050897, 7050898,
7050905, 7050907, 7050922, 7050923, 7050924, 7050925, 7050974,
7050975, 7050976, 7050978, 7050979, 7050985, 7050988, 7050989,
7050990, 7050991, 7051074, 7051075, 7051215, 7051216, 7051228,
7051229, 7051231, 7051233, 7051234, 7061230, 7061636, 7061650,
7061654, 7061656, 7061658, 7061659, 7061660, 7061661, 7061662,
7061663, 7061806, 7062151, 7062152, 7062153, 7062154, 7062168,
7062169, 7062170, 7062171, 7062172, 7062173, 7062174, 7062177,
7062178, 7062256, 7062284, 7062285, 7062286, 7062287, 7062288,
7062429, 7062430, 7072699, 7072700, 7072701, 7072702, 7072703,
7072704, 7072705, 7072838, 7072851, 7073014, 7073015, 7073083,
7083481, 7085481, 7094727, 7094728, 7094730, 7094731, 7094732,
7094733, 7094734, 7094735, 7094736, 7094742, 7094743, 7094745,
7094747, 7094748, 7095603, 7095604, 7095605, 7095606, 7095608,
7095609, 7095610, 7095611, 7095612, 7095613, 7106304, 7106310,
7106311, 7106312, 7117236, 7117237, 7117238, 7117275, 7117276,
7117278, 7117277, 7117279, 7117280, 7117281, 7117282, 7117283,
7117284, 7128256, 7128257, 7128258, 7128259, 7128260, 7128266,
7128267, 7128268, 7128270, 8010192, 8010255, 8010256, 8010257,
8010258, 8010259, 8010260, 8010261, 8017991, 8019759, 8019760,
8019768, 8019769, 8019771, 8019774, 8019775, 8019776, 8019790,
8019792, 8019793, 8019866, 8019867, 8019868, 8019869, 8019870,
8019871, 8019872, 8019873, 8019874, 8019875, 8019877, 8019902,
8020601, 8021073, 8030808, 8031515, 8031516, 8031517, 8031531,
8031532, 8031533, 8031534, 8031535, 8031536, 8031537, 8031538,
8031539, 8031540, 8031541, 8031542, 8031582, 8031583, 8031585,
8031587, 8031589, 8031590, 8031591, 8031691, 8031778, 8031779,
8031780, 8031781, 8031782, 8031784, 8031785, 8031786, 8031801,
8031802, 8031803, 8031804, 8031805, 8031806, 8031807, 8031808,
8031809, 8031810, 8031811, 8031812, 8031818, 8031819, 8031971,
8032072, 8032137, 8032138, 8032141, 8032143, 8032145, 8032146,
8032148, 8032149, 8032150, 8032173, 8042375, 8042384, 8042476,
8042703, 8053438, 8053943, 8053944, 8053945, 8053946, 8053947,
8053949, 8053950, 8053952, 8053953, 8053954, 8053963, 8054025,
8054026, 8054200, 8054201, 8054202, 8054203, 8054204, 8054205,
8054206, 8054207, 8054208, 8054209, 8054288, 8054289, 8054290,
8054291, 8054292, 8054293, 8054294, 8054295, 8054296, 8054297,
8054299, 8054341, 8064785, 8064843, 8064844, 8064845, 8064846,
8064847, 8064848, 8064849, 8064850, 8064851, 8064852, 8064853,
8064854, 8064855, 8064856, 8064857, 8064858, 8064859, 8064860,
8065138, 8075505, 8076072, 8076073, 8076074, 8076076, 8076077,
8076078, 8076079, 8076097, 8076099, 8076100, 8076101, 8076102,
8076105, 8076106, 8076149, 8076150, 8076151, 8076152, 8086579,
8086480, 8086577, 8086578, 8086580, 8086581, 8086582, 8086583,
8086584, 8086585, 8086586, 8086587, 8086588, 8086589, 8086590,
8086591, 8086592, 8086594, 8086714, 8086715, 8086716, 8086717,
8097483, 8097484, 8097485, 8097486, 8097487, 8097488, 8097489,
8097490, 8097492, 8097493, 8097494, 8097495, 8098122, 8108729,
8108730, 8108731, 8108732, 8110232, 8110233, 8119448, 8119449,
8119450, 8119451, 8119452, 8119453, 8119454, 8119455, 8119456,
8119457, 8119458, 8119459, 8119460, 8119461, 8119462, 8119463,
8119464, 8119465, 8119466, 8119467, 8119468, 8119469, 8119470,
8119830, 8119831, 8119836, 8119978.  EXP dates are throughout
1999 and 2000.

MANUFACTURER
Novapharm Ltd., Scarborough, Ontario, Canada.

RECALLED BY
Granutec, Inc., Wilson, North Carolina, by letter on December 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

188,000,000 tablets were distributed.

REASON
Product exceeds impurity level.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
Platelets. Recall #B-373-9.

CODE
Unit #W34305.

MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.

RECALLED BY
Manufacturer, by telephone on September 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY

1 unit was distributed.

REASON
Blood product tested negative for the antibody to the human T-lymphotropic virus type I and II (anti-HTLV-I/II), but was collected from a donor who previously tested repeatedly reactive for anti-HTLV-1/2.

________
PRODUCT
Red Blood Cells. Recall #B-482-9.

CODE
Unit # 5725237 and 9542771.

MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, Oklahoma.

RECALLED BY
Manufacturer, by letter dated either December 17, 1996 or April 21, 1997. Firm-initiated recall Complete.

DISTRIBUTION
Oklahoma, Massachusetts.

QUANTITY

2 units were distributed.

REASON
Blood products were collected from donors who reported travel to areas designated as endemic for malaria.

________
PRODUCT
Platelets. Recall #B-487-9.

CODE
Unit numbers: 34019793, 34019795, 34019797.

MANUFACTURER
W.E and Lela I. Stewart Blood Center, Inc., Tyler, Texas.

RECALLED BY
Manufacturer, by telephone on September 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY

3 units were distributed.

REASON
Blood products were labeled with extended expiration dates.

________
PRODUCT
Red Blood Cells. Recall #B-488-9.

CODE
Unit #391753.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by letter dated April 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY

1 unit was distributed.

REASON
Blood product was collected from a donor who traveled to an area considered endemic for malaria

. ________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-500/502-9.

CODE
Unit #434613.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by letter dated December 16, 1996. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY

1 unit of each component was distributed.

REASON
Blood products were collected from a donor who was deferred for body piercing.

________
PRODUCT
Platelets, Pooled. Recall #B-504-9.

CODE
Unit #9400834.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis.

RECALLED BY
Manufacturer, by telephone on December 8, 1997. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY

1 unit was distributed.

REASON
Blood product was labeled with an extended expiration time.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
Red Blood Cells. Recall #B-483-9.

CODE
Unit #1916921.

MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, Indiana.

RECALLED BY
Manufacturer, by telephone on August 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana.

QUANTITY

1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

________
PRODUCT
Red Blood Cells, Irradiated. Recall #B-489-9.

CODE
Unit numbers: 0509954, 0509815, 0509968.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by telephone on or about January 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY

3 units were distributed.

REASON
Blood products were labeled with extended expiration dates.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-496/499-9.

CODE
Unit numbers: a) 38FC42733, 38FC42735, 38FC42745, 38FC42750, 38FC42754, 38FC42758, and 38FC42761; b) 38FC42733; c) 38FC42761; d) 38FC42733.

MANUFACTURER
American Red Cross Blood Services, Fort Wayne, Indiana.

RECALLED BY
Manufacturer, by telephone or by letter on December 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana and New York.

QUANTITY

a) 7 units; b) 1 unit; c) 1 unit; d) 1 unit was distributed.

REASON
Blood products, collected in expired collection bags.

________
PRODUCT
Red Blood Cells, Leukoreduced. Recall #B-503-9.

CODE
Unit numbers: 0571084, 0572105, 0572106, 0572113, 0572114, 0572231, 0572232, 0572233, 0572235, 0572239.

MANUFACTURER

Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by letter dated April 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY

10 units were distributed.

REASON
Blood products may have remained at room temperature for an unacceptable length of time.

________
PRODUCT
Red Blood Cells, Leukoreduced. Recall #B-505-9.

CODE
Unit numbers: 451567, 481724, 483175.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by letter dated April 15, 1997. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY

3 units were distributed.

REASON
Blood products were leukoreduced by filtration greater than 5 days past the collection date.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Source Leukocytes. Recall #B-506/508-9.

CODE
unit #9885189.

MANUFACTURER
Hoxworth Blood Center, Cincinnati, Ohio.

RECALLED BY
Manufacturer, by letter dated December 12, 1997. Firm-initiated recall complete.

DISTRIBUTION
Ohio and Florida.

QUANTITY

1 unit of each component was distributed.

REASON
Blood products were incorrectly tested for syphilis.

________
UPDATE
Fresh Frozen Plasma for Manufacturing Non-Injectable Products, which appeared in the February 17, 1999 Enforcement Report should read Recall #B-479-9.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
PRODUCT
Heparin 10 u/mL Flush Syringe, Intravenous Catheter a) Catalog No. RAH-02-03-100; b) Catalog No. RAH-10-12-100. Recall #Z-177/178-9.

CODE
a) Lot No. 5661-0914-1200-FL; b) and Lot No. 5781-0914-1205-FL.

MANUFACTURER
Rocap Division of Sabratek Corporation, Orlando, Florida.

RECALLED BY
Manufacturer, by telephone on September 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland, Florida, Minnesota.

QUANTITY

12 cases (4 packs per case) were distributed.

REASON
The syringes may be labeled with the incorrect Heparin Sodium Volume.

________
PRODUCT
Model Ceralas D-series Laser System, for use in surgery. Recall #Z-589-9.

CODE
None.

MANUFACTURER
CeramOptec, Inc., East Longmeadow, Massachusetts.

RECALLED BY
Manufacturer. FDA approved the firm's corrective action plan on January 22, 1999. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY

38 units were distributed.

REASON
The device failed to comply with 21 CFR 1040.11(a)(2) in that the operator's manual lacked calibration procedures.

________
PRODUCT
Model Dentek LD 15 Laser System, used in dentistry. Recall #Z-590-9.

CODE
None.

MANUFACTURER
Dentek-Lasersystems, GmbH, Graz, Austria.

RECALLED BY
Diolase Tech, San Clemente, California (importer). FDA approved the firm's corrective action plan on February 5, 1999. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

11 units were distributed.

REASON
The device failed to comply with 21 CFR 1040.11(a)(2) in that the operator's manual lacked calibration procedures.

________
PRODUCT
Model LaserLite Laser System, used in dermatology. Recall #Z-591-9.

CODE
None.

MANUFACTURER
Diomed Ltd./Laser Lite, Inc., Boston, Massachusetts.

RECALLED BY
Manufacturer. FDA approved the firm's corrective action plan on February 4, 1999. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

20 units were distribution.

REASON
The device failed to comply with 21 CFR 1040.11(a)(2) in that the operator's manual lacked calibration procedures.

________
PRODUCT
Datascope Expert Monitor, Model #0998-00-0145-01, indicated in those situations where observations of one or more of the following parameters on an individual patient may be required: ECG, respiration, non-invasive and/or invasive blood pressures, temperature, Pulse oximetry, and cardiac output. Recall #Z-594-9.

CODE
All serial numbers.

MANUFACTURER
Datascope Corporation, Paramus, New Jersey.

RECALLED BY
Manufacturer, by letter on August 12, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Pennsylvania, Texas, Virginia, Washington state, Wisconsin, international.

QUANTITY

183 units were distributed.

REASON
The device may report possible high Non-Invasive Blood Pressure (NIBP) measurements.

________
PRODUCT
Intra-aortic Balloon Pumps, used during medical procedures inconjunction with Intra-Aortic Balloons: a) System 96; b) System 97; c) System 97e. Recall #Z-597/599-9.

CODE
Model numbers: 0998-00-0104-01, 03, 04, 10, 11, 12, 13, 15, 16, 17, 24, 33, 40, 53, 55, 56, 57, 58, 60, 61, 62, 63, 64, 65, 83, 86; 0998-00-0124-10, 11, 13, 23, 31, 33, 41, 43, 50, 53; 0998-00-0142-53, 55, 57, 58, 61, 64, 65, 83.

MANUFACTURER
Datascope Corporation, Patient Monitoring Division, Paramus, New Jersey.

RECALLED BY
Manufacturer, by letter April 27, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY

1,163 units (domestic) and 1,115 units (international) were distributed.

REASON
The power supply may fail at start up or during operation of the IABP.

________
PRODUCT

BioMend(tm) Template Material (Non-Implantable), Part No. 4627 
10/94, Lot No. 18860695, packed with  BioMend(tm) Absorbable   
Collagen Membrane:
a) BioMend(tm) Template Material, Catalog No. 0103, 15mm x 20mm;
b) BioMend(tm) Template Material, Catalog No. 0105, 20mm x 30mm;
c) BioMend(tm) Template Material, Catalog No. 0107, 20mm x 40mm.
Recall #Z-600/602-9.

CODE

Lot Numbers:                                         EXP Date:
BioMend 7002650 packaged with Template 18860695      Nov. 1999
BioMend 7002660 packaged with Template 18860695      Jan. 2000
BioMend 7004210 packaged with Template 18860695      Dec. 1999
BioMend 7004220 packaged with Template 18860695      Feb. 2000
BioMend 7004230 packaged with Template 18860695      Apr. 2000
BioMend 7004240 packaged with Template 18860695      Feb. 2000
BioMend 7004250 packaged with Template 18860695      Mar. 2000
BioMend 7004260 packaged with Template 18860695      Mar. 2000
BioMend 8000710 packaged with Template 18860695      Jun. 2000
Product Code:  Template is identified as part number 4627
10/94.

MANUFACTURER
Integra Life Sciences Corporation, Griffith Micro Science, Plainsboro, New Jersey (contract sterilizer) Sulzer Calcitek, Inc. (Sulzer Medical), Carlsbad, California (distributor).

RECALLED BY
Colla-tec, Inc., an Integra Life Sciences Corp. Company, Plainsboro, New Jersey, by letters on October 1-2 and 5-8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California.

QUANTITY

17,631 templates were distributed.

REASON
The template may have been improperly packaged due to damaged seals, therefore compromising the sterility of the device.

________
PRODUCT

DLP Elongated One-Piece Arterial Cannula, Various Model
a)  20 Fr. Elongated One Piece Arterial (EOPA) Cannula w/Vented
Connector, Product Code 77420,;
b) 22 Fr. Elongated One Piece Arterial (EOPA) Cannula w/Vented
Connector, Product Code 77422;
c) 20 Fr. Elongated One Piece Arterial (EOPA) Cannula
w/Non-Vented Connector, Product Code 77520;
d) 22 Fr. Elongated One Piece Arterial (EOPA) Cannula
w/Non-Vented Connector, Product Code 77522;
e) 22 Fr. Elongated One Piece Arterial (EOPA) Cannula w/Shortened
Body, Product Code E3139;
f) 22 Fr. Elongated One Piece Arterial (EOPA) Cannula w/Connector
Plug, Product Code E3150;
g) 20 Fr. Elongated One Piece Arterial (EOPA) Cannula w/Suture
Collar, Product Code E3229;
h) 22 Fr. Elongated One Piece Arterial (EOPA) Cannula w/Shortened
Body, Product Code E3235;
i) 20 Fr. Elongated One Piece Arterial (EOPA) Cannula w/Carmeda
Heparin Coating, Product Code CB77420;
j) 20 Fr. Elongated One Piece Arterial (EOPA) Cannula w/Carmeda
Heparin Coating, Product Code CB77422;
k) 20 Fr. Elongated One Piece Arterial (EOPA) Cannula w/Carmeda
Heparin Coating, Product Code CB77520;
l) 22 Fr. Elongated One Piece Arterial (EOPA) Cannula w/Carmeda
Heparin Coating, Product Code CB77522.  Recall #Z-603/614-9.

CODE

Lot numbers:  a) 6970-6003, 6970-7002, 6970-9007,  6970-9009,
6971-1003, 6971-2007, 6971-2008, 6980-2007, 6980-3002, 6980-3001,
6980-3003, 6980-3004, 6980-4002, 6980-4005, 6980-5001, 6980-6009,
6980-7003, 6980-7004, 6980-8001, 6980-8005, 6980-9005, 6980-9009,
6981-0004, 6981-1001, 6981-1005;
b) 6970-6003, 6970-7002, 6970-9003, 6971-0009, 6971-2002,
6980-1007, 6980-3005, 6980-3006, 6980-3008, 6980-4006, 6980-6003,
6980-6007, 6980-6008, 6980-6009, 6980-7008, 6980-8001, 6980-8004,
6980-8008, 6980-9001, 6980-9005, 6981-0004, 6981-0005;
c) 6970-6003, 6970-7002, 6970-9001, 6971-0001, 6980-1001,
6980-4007, 6980-6008, 6980-6009, 6980-7002, 6980-7007;
d) 6970-6003, 6970-7001, 6970-9002, 6970-9005, 6971-2002,
6971-2008, 6971-2009, 6980-2003, 6980-3001, 6980-4002, 6980-4004,
6980-5001, 6980-6003, 6980-7001, 6980-8001, 6980-8004, 6980-9009,
6981-0009, 7981-2024;
e) 6980-2003;
f) 6980-3002, 6980-4005;
g) 6981-1008;
h) 6981-1001, 6981-1002;
i) 9807003047, 9808003005, 9809001694, 9810000288;
j) 9809002596;
k) 9804001127, 9805000217, 9805001800, 9806003059;
l) 9804001601, 9805002047.

MANUFACTURER
Medtronic, Inc., Medtronic DLP, Grand Rapids, Michigan (non-heparin coated); Medtronic Cardiopulmonary, Anaheim, California (heparin coated).

RECALLED BY
Medtronic, Inc., Medtronic DLP, Grand Rapids, Michigan, by letters dated December 17 and 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY

20,056 units were distributed.

REASON
The tip of the introducer may traumatize the posterior wall of the ascending aorta during insertion.

________
UPDATES
Oral RAE Tracheal Tubes, Recall #Z-573/576-9, which appeared in the February 10, 1999 Enforcement Report should read:

RECALLED BY
Mallinckrodt, Inc., St. Louis, MO, by letter dated 11/18/98 and by FAX on 1/19/99. Firm-initiated field correction complete. Firm provided additional instructions to assure the connector is firmly seated in the tracheal tube and breathing circuit.

Oral RAE Trachael Tubes (Mallinckrodt Medical), Recall #Z-577-9, which appeared in the February 10, 1999 Enforcement Report should read: CODE
: Lot #M035030.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II

________
PRODUCT
LymDyp S (ready to use pet dip) (For the treatment of dermatoses and parasites for dogs, cats, puppies and kittens). Recall #V-036-9.

CODE
Lots numbers: J258, F158, F148, E178, F168 (12 oz containers) Lot D188 (one gallon container).

MANUFACTURER
DVM Pharmaceuticals, Medley, Florida.

RECALLED BY
Manufacturer, by letter fax on January 11, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
16,285 12 oz. containers, 224 one gallon containers were distributed.

REASON
Product is manufactured with two (2) levels of citrus fragrance (1% and 2%) Only the products containing the 2% CITRUS FRAGRANCE is involved in the recall. The 2% citrus fragrance is causing severe burns/reactions in kittens after use.

END OF ENFORCEMENT REPORT FOR FEBRUARY 24, 1999.

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