March 24, 1999 99-12
CODE
No manufacturing codes and no expiration dates. Products can be
identified by UPC symbols as follows: a) 092719361831;
b) 092719361817.
MANUFACTURER
Hagavia Wafer Products Ltd., Netivot, Israel.
RECALLED BY
Dangold, Inc., Flushing, New York, by letter on January 12, 1999,
and by press release December 31, 1998, and January 8, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
New York, New Jersey, California, Massachusetts, Florida, Texas,
Tennessee, North Carolina, Illinois, Michigan, Maryland,
Pennsylvania.
QUANTITY
Approximately 736 cases (8 packages/case) were distributed with
deficient label.
REASON
Product contains hazelnuts, but does not declare this ingredient
in the statement of ingredients in the English language.
________
PRODUCT
SunBurst Bar-B-Que w/Slaw Sandwich, 3.25 ounces.
Recall #F-229-9.
CODE
All products on the market at the time of the recall.
MANUFACTURER
SunBurst Foods, Inc., Goldsboro, North Carolina.
RECALLED BY
Manufacturer, by letter dated October 27, 1998. Firm-initiated
recall complete.
DISTRIBUTION
North Carolina, South Carolina, Virginia.
QUANTITY
Firm estimates none remains on the market.
REASON
Product contains undeclared eggs.
________
PRODUCT
Royal Baltic brand Smoked Shad, packaged in vacuum packed
flexible plastic bags, or distributed as whole,
unpackaged/unlabeled fish. Recall #F-240-9.
CODE
Lot #2710.
MANUFACTURER
Royal Baltic Ltd., Brooklyn, New York.
RECALLED BY
Manufacturer, by letter, telephone, and press release on November
9, 1998. Completed recall resulted from sample analysis and
follow-up by the New York Department of Agriculture and Markets.
See also FDA press statement dated November 13, 1998.
DISTRIBUTION
New York, California, Oregon, Washington state Illinois.
QUANTITY
471.8 pounds were distributed.
REASON
Product was contaminated with Listeria monocytogenes.
________
PRODUCT
Lindt Truffles and Gourmet Truffles: a) Lindt Chocolate Truffles milk variety b) Lindt Chocolate Truffles dark variety c) Lindt Chocolate Truffles white variety d) Lindt Chocolate Truffles milk hazelnuts variety e) Lindt Chocolate Truffles amaretto variety f) Lindt Chocolate Truffles mint variety g) Lindt Chocolate Truffles cinnamon variety h) Lindt Chocolate Truffles orange variety I) Lindt Gourmet Truffles milk/amaretto variety j) Lindt Gourmet Truffles milk/orange variety k) Lindt Gourmet Truffles dark/dark variety l) Lindt Gourmet Truffles milk/milk variety m) Lindt Gourmet Truffles white/dark variety n) Lindt Gourmet Truffles dark/white variety. Recall #F-241/254-9.
CODE
All product on the market which does not contain the statement
"May contain traces of peanuts/nuts".
MANUFACTURER
Lindt & Sprungli (USA), Inc., Stratham, New Hampshire.
RECALLED BY
Manufacturer, by press release on January 7, 1999, by letter on
January 7 and 8, 1999, and by E-mail on January 11, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Canada, Australia.
QUANTITY
Approximately 400,000 pounds.
REASON
Products may be contaminated with peanut residue.
________
PRODUCT
a) Nigiri Sushi, net weight 6 pounds; b) California Roll,
(imitation crabmeat sushi), net weight 8 pounds.
Recall #F-255/256-9.
CODE
a) All lot numbers beginning with 40; b) All lot numbers
beginning with 10.
MANUFACTURER
Fifo Food Systems, Inc., Gardena, California.
RECALLED BY
Manufacturer, by fax on January 20, 1999. Firm-initiated recall
complete.
DISTRIBUTION
California and Illinois.
QUANTITY
Undetermined.
REASON
Products contain undeclared eggs.
________
PRODUCT
Kedem brand Grape Juices in 650 ml, 1 liter, and 1.5 liter glass bottles in the following flavors: a) Kedem brand Naturel Blanc Grape Juice (French label), with a white and orange label, labeled in part, "*** KEDEM *** Naturel Blanc *** GRAPE JUICE *** JUS DE RAISIN *** PRODUCED BY *** KEDEM FOOD PRODUCTS ***" in 650 ml, 1 liter, and 1.5 liter glass bottles; b) Kedem brand Gold Grape Juice (French label), with a brown label containing black lettering, labeled in part, "*** KEDEM *** Naturel *** BLANC *** GRAPE JUICE *** JUS DE RAISIN *** PRODUCED BY *** KEDEM FOOD PRODUCTS ***" in 650 ml, 1 liter, and 1.5 liter glass bottles; c) Kedem brand Peach Grape Juice (French label), with a white and cream colored label, labeled in part, "*** KEDEM *** Peach *** GRAPE JUICE *** Jus de Peche *** PRODUCED BY KEDEM *** FOOD PRODUCTS ***"in 650 ml, 1 liter, and 1.5 liter glass bottles; d) Kedem brand Naturel Blush Rougir Grape Juice (French label), with white and peach colored label, labeled in part, "*** KEDEM *** Naturel *** Blush *** ROUGIR *** GRAPE JUICE *** JUS DE RAISIN *** PRODUCED BY *** KEDEM FOOD PRODUCTS ***"in 650 ml, 1 liter, and 1.5 liter glass bottles; e) Concord Grape Juice i) Kedem brand in 650 ml, 1 liter, and 1.5 liter glass bottles with white and purple labels,(French label) labeled in part, "*** KEDEM *** Naturel Concord Rouge *** GRAPE JUICE *** JUS DE RAISIN *** PRODUCED BY *** KEDEM FOOD PRODUCTS ***" ii) Kedem brand in 650 ml, 1 liter, and 1.5 liter glass bottles with white and purple labels, (Spanish label) labeled in part " *** KEDEM *** Hecho con *** Uvas Concord *** JUGO DE UVA *** PRODUCTO EXPORTADO POR: *** Royal Wine Co. ***" iii) Season brand in 650 ml glass bottles labeled in part, "*** SEASON *** BRAND *** Grape Juice *** CONCORD *** Net Wt. 22 Fl. Oz. (1 Pt. 6 Oz.) 650 ml *** DISTRIBUTED BY *** SEASON PRODUCTS CORP. *** IRVINGTON, N.J. 07111 *** PRODUCT OF U.S.A. ***." Recall F-258/262-9.
CODE
All product on the market failing to declare the presence of
sulfites.
MANUFACTURER
Royal Wine Corporation, doing business as Kedem Food Products
Company, Marlboro, New York (bulk juice).
RECALLED BY
Royal Wine Corporation, doing business as Kedem Food Products
Company, Brooklyn, New York (bottler), by letter dated January
28, 1999. Firm-initiated field correction (relabeling)
ongoing.
DISTRIBUTION
New Jersey, Canada, Mexico.
QUANTITY
Firm estimated that 20,000 cases (8 or 12 bottles per case) of
the Kedem grape juices with the French labels; approximately 900
cases (8 or 12 bottles per case) of the Kedem Concord Grape
Juice; approximately 210 cases (12 bottles per case) of the
Season brand juice were distributed.
REASON
Products contain undeclared sulfites.
________
PRODUCT
Pusan Clam Meat Fishcake in individual 12.3 ounce vacuum-packaged
packages, and in bulk. Recall #F-263-9.
CODE
Catalog #33650 10010 on each label.
MANUFACTURER
Doo Rae Trading Company, Fullerton, California.
RECALLED BY
Manufacturer, by telephone on January 8, 1999, and by press
release on January 13 and 14, 1999. Firm-initiated recall
complete.
DISTRIBUTION
California and New York.
QUANTITY
466 cases (50 units per case) and 5,553 bulk pounds were
distributed.
REASON
Product contains undeclared egg whites and undeclared wheat
gluten.
________
PRODUCT
The Egg Roll Castle Egg Rolls in shipping boxes containing 20 packaages consisting of 12 egg rolls each: a) Vegetable Egg Roll (lumpia) 15 ounces, UPC 76241412340; b) Seafood Vegetable Egg Roll (Lumpia) 15 ounces, UPC 76241443210; c) Vegetable Egg Roll with Pork Flavor (Lumpia) 15 ounces, UPC 76241426789; d) Vegetable Egg Roll with Beef Flavor (Lumpia) 15 ounces, 76241498650; e) Vegetable Egg Roll with Chicken Flavor (Lumpia) 15 ounces, UPC 76241400568. Recall #F-264/268-9.
CODE
All product on the market at the time of the recall.
MANUFACTURER
The Egg Roll Castle Company, San Diego, California.
RECALLED BY
Manufacturer, by letter on January 29, 1999, and press release on
February 1, 1999. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY
2,800 cases were distributed.
REASON
Product contains undeclared egg whites.
CODE
Lot numbers: a) BF01999, BF03499, and BF03699;
b) BF35098 and BF02099; c) BF34998, BF01999, and BF03499.
MANUFACTURER
Good Humor Breyers Ice Cream, Framingham, Massachusetts.
RECALLED BY
Good Humor Breyers Ice Cream, Green Bay, Wisconsin, by telephone
on February 23, 1999, and by letter on February 24, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY
36,780 pints were distributed.
REASON
Products may contain pieces of metal.
________
PRODUCT
Various sandwiches under the SunBurst label: a) Shaved Ham & Cheese, 3.75 oz b) Home Made Chicken Salad, 4.0 ounces c) Roast Beef, 3.75 ounces d) Turkey on Wheat, 3.5 ounces e) Pimento Cheese Spread, 3.75 ounces f) Ham & Turkey, 5.0 ounces g) 1/4 lb. Bacon Cheeseburger, 5.0 ounces h) Steak & Cheese Sub, 5.75 ounces i) Breaded Chicken, 5.5 ounces j) Deli Deluxe Turkey, Ham & Cheese Sub, 7.5 ounces. Recall #F-230/239-9.
CODE
All products on the market at the time of recall.
MANUFACTURER
SunBurst Foods, Inc., Goldsboro, North Carolina.
RECALLED BY
Manufacturer, by letter dated October 27, 1998. Firm-initiated
recall complete.
DISTRIBUTION
South Carolina, North Carolina, Virginia.
QUANTITY
Firm estimates none remains on the market.
REASON
Products' label do not declare the ingredients of mayonnaise.
________
PRODUCT
Inari Sushi (tofu sushi), net weight 6.50 pounds.
Recall #F-257-9.
CODE
All lot numbers beginning with 30.
MANUFACTURER
Fifo Food Systems, Inc., Gardena, California.
RECALLED BY
Manufacturer, by fax on January 20, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
California and Illinois.
QUANTITY
Undetermined.
REASON
Product contains undeclared wheat.
CODE
Lot numbers: 4363C, 5542B, 6191A, 6192A, 8034B, 8716B, 4363B,
5542A, 6191B, 6192B, 6192C, 8034A, 8276, 8716A, and 9315.
MANUFACTURER
LNK International, Inc, Hauppauge, New York.
RECALLED BY
AmeriSource Health Services Corporation, doing business as
American Health Packaging, Columbus, Ohio (repacker/responsible
firm), by letter on March 2, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Texas, Idaho, Kentucky, Florida, Arizona, Massachusetts, New
Jersey, Wisconsin, Pennsylvania, Virginia, Indiana, Oklahoma, New
York, Illinois.
QUANTITY
881 units of 25 blister cards X 30 tablets, and 27,558 units of
10 blister cards X 10 tablets were distributed; firm estimated
that 654 units (25 X 30) and 20,874 units (10 X 10) remained in
distribution channels at time of recall initiation.
REASON
Stability - Out of specification for percent (%) free salicylic
acid.
________
PRODUCT
Oxygen, USP, in high pressure M6 size cylinders.
Recall #D-141-9.
CODE
Lot #021999X1.
MANUFACTURER
The Complete Home Care, Massillon, Ohio.
RECALLED BY
Manufacturer, by telephone and by letter on March 2, 1999.
Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
6 cylinders.
REASON
Current good manufacturing practice deviations; including but not
limited to improper identity and strength.
________
PRODUCT
Leep Redikit for Gynecological Loop Electrosurgical Excision
Procedure, Part #6060. Recall #D-143-9.
CODE
Lot Numbers: 711054L 711144L 711184L 711194L 712124L 712164L 712174L 712184L 712314L 801224L 801234L 802184L 802254L 803054L 803124L 803234L 804014L 804024E 804204E 804294E 80810E 81008E 81024E 81027E 81110E 81122E 81125E 90120E 90129E 90201E.
MANUFACTURER
Cooper Surgical, Inc., Shelton, Connecticut.
RECALLED BY
Manufacturer, by letter on March 1, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
27,622 kits were distributed.
REASON
Lack of assurance of sterility for Novocol brand/manufactured
Octocaine 100 (Lidocaine HCL 2% and Epinephrine 1:100,000) 1.8
Ml Cartridges packaged in each kit.
________
PRODUCT
Naturade Children's Cough Syrup, OTC, (Glyceryl Guaiacolate
(Guaifenesin)) 150 mg/15 ml, in 4 ounce and 8 ounce bottles.
Recall #D-144-9.
CODE
Lot #I44047 EXP 9/99.
MANUFACTURER
Irenda Corporation, Los Angeles, California.
RECALLED BY
Naturade, Inc., Paramount, California, by letter dated March 10,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Arizona, California, Colorado, Connecticut, Iowa, Illinois,
Indiana, Missouri, New Hampshire, New Jersey, New York,
Pennsylvania, Washington state, Wisconsin.
QUANTITY
7,356 4-ounce bottles and 984 8-ounce bottles were
distributed.
REASON
Mislabeling - The directions for children 2 to under 6 years of
age indicate dosage of 1 (one) tablespoon every 4 hours instead
of the correct 1 (one) teaspoon every 4 hours.
_______
PRODUCT
Mapap Tablets, Regular Strength (Acetaminophen) 325 mg, in 1000
tablet bottles, OTC labeled as an aspirin free pain reliever,
distributed by Major Pharmaceuticals. NDC #0904-1982-80.
Recall #D-145-9.
CODE
Lot #98M422 EXP 12/01.
MANUFACTURER
PDK Laboratories, Inc., Hauppauge, New York.
RECALLED BY
Manufacturer, by letters faxed on February 18, 1999, and mailed
on February 23, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Indiana and California.
QUANTITY
2,797 bottles were distributed; firm estimated that 1,327 bottles
remained on market at time of recall initiation.
REASON
Tablet mix-up - Some acetaminophen 500 mg tablets were mixed in
bottles of 325 mg tablets.
Synthroid (levothyroxine sodium, USP) Tablets, Rx indicated as a replacement or supplement therapy in patients of any age or state with hypothyroidism of any etiology: a) Synthroid Tablets (Levothyroxine Sodium Tablets, USP), 88 mcg (0.088 mg), 100 tablets in plastic bottles; b) Synthroid Tablets (Levothyroxine Sodium Tablets, USP), 100 mcg (0.1 mg), 100 tablets in plastic bottles; c) Synthroid Tablets (Levothyroxine Sodium Tablets, USP), 150 mcg (0.15 mg), 100 tablets in plastic bottles; d) Synthroid Tablets (Levothyroxine Sodium Tablets, USP), 175 mcg (0.175 mg), 100 tablets in plastic bottles. Recall #D-136/139-9.
CODE
Lot numbers: a) 880128, 880138, 880148A, 880168A, 880178;
b) 1000818; c) 1500388; d) 1750088A, 1750098, 1750118, 1750118A,
1750128A, 1750138, 1750148, 1750158.
MANUFACTURER
BASF Pharmaceutical Company, Jayuya, Puerto Rico.
RECALLED BY
Knoll Pharmaceutical Company, Mount Olive, New Jersey, by letter
on November 28, 1998. Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
Lot # Qty Distributed (100 count bottles) 80128 28,140 880138 37,272 1750088A 32,256 1750098 32,228 1750118 5,388 1750118A 10,920 880148A 25,716 880168A 27,540 1750128A 32,136 1750138 37,992 1500388 3,288 1000818 1,356 880178 13,056 1750148 6,012 1750158 5,784.
REASON
Stability - Product may not maintain potency for the labeled
expiration date due to packaging defect.
_________
PRODUCT
Epinephrine Inhalation Aerosol, USP, 5.5 mg/ml, 1/2 ounce (15
ml), for the temporary relief of shortness of breath, tightness
of chest, and wheezing due to bronchial asthma disorders,
distributed under the Walgreen, Osco, Eckerd, CVS, Menley and
James, Marquee, Longs, Select Brands, Drug Guild, Sav-on,
American Fare, Major, Quality Choice and Rite Aid labels.
Recall #D-140-9.
CODE
Lot No. NDC No. Size Exp Date Label RN7836 11917-003-93 15 ml 04/00 Walgreens 12810-970-99 15 ml 04/00 Osco Drug 19458-5066-1 15 ml 04/00 Eckerd 50428-583-20 15 ml 04/00 CVS 87900-970-99 15 ml 04/00 Menley & James RN7839 076-00970-15 15 ml 04/00 Marquee 12333-9477-1 15 ml 04/00 Longs 15127-970-15 15 ml 04/00 Select Brands 19458-9001-1 15 ml 04/00 Eckerd 26032-970-15 15 ml 04/00 Drug Guild 37097-970-15 15 ml 04/00 Sav-on 7200-1755-4 15 ml 04/00 American Fare RN7841 0904-7770-35 15 ml 05/00 Major 11161-970-99 15 ml 05/00 Quality Choice 11822-3479-7 15 ml 05/00 Rite Aid 11917-003-93 15 ml 05/00 Walgreens 12810-970-99 15 ml 05/00 Osco Drug 7200-1755-5 15 ml 05/00 American Fare.
MANUFACTURER
Alpharma, U.S. Pharmaceutical Division, Baltimore, Maryland.
RECALLED BY
Manufacturer, by letter on or about January 20, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Lot No. NDC SHIPPED RN7836 11917-003-93 13860 12810-970-99 5976 19458-5066-1 9900 50428-583-20 72 87900-970-99 22704 RN7839 076-00970-15 2844 12333-9477-1 3996 15127-970-15 4356 19458-9001-1 13212 26032-970-15 1368 37097-970-15 2844 7200-1755-4 12384 RN7841 0904-7770-35 2844 11161-970-99 2844 11822-3479-7 10368 11917-003-93 14796 12810-970-99 4284 7200-1755-5 9720.
REASON
Failure to meet the USP criteria for unit spray and total
doses.
________
PRODUCT
Lithobid - Lithium Carbonate, USP 300 mg Slow-Release Tablets, Rx
in 1,000 tablet bottles, indicated in the treatment of manic
episodes of manic depressive illness. Recall #D-142-9.
CODE
Lot #88406.
MANUFACTURER
Solvay Pharmaceuticals, Inc., Marietta, Georgia.
RECALLED BY
Manufacturer, by letter on February 22, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
1,378 bottles were distributed.
REASON
Dissolution failure at 18 month stability testing.
CODE
Unit numbers: a) 09J08018, 09K04843, 09F29916, 09G84369, 09R31245, 09R31539, 09R31939, 09R32596, 09R33145, 09R33635, 09R35254, 09R35799, 09R36154, 09R47412, 09R48025, 09T76771, 09T80032, 09T89873, 09T93381, 09T99036, 09T07467, 09R25746, 09R26498, 09T81072, 09T96219, 09T12669, 09T27458 b) 09J87941, 09G27971, 09H76084; c) 09J07882, 09G24114 d) 09R35254, 09R35799, 09T80032, 09T81072, 09T96219 e) 09P35110, 09P36786, 09P39521 f) 09Q06362, 09F29916, 09R31245, 09R31539, 09R32596, 09R33635, 09T12669 g) 09P39521, 09R31939, 09R47412, 09R48025, 09T81072, 09T96219, 09T27458 h) 09G17654, 09J08018, 09T76771, 09T89873, 09T99036, 09R25746, 09T85688, 09T00629 i) 09G91771, 09H62717, 09J12080, 09T85688, 09T76656, 09T09471 j) 09K04843, 09Q06362, 09F29916, 09J87941 09G82515, 09G91771, 09H62717, 09J12080, 09H76084, 09R31245, 09R31539, 09R32596, 09R33145, 09R33635, 09R35254, 09R35799, 09R36154, 09T80032, 09T93381, 09T07467, 09T12072, 09R26498, 09T76656, 09T09471, 09T12669.
MANUFACTURER
American Red Cross Blood Services, Omaha, Nebraska.
RECALLED BY
Manufacturer, by letter dated January 14, 1997, and on January
13, 1997. Firm-initiated recall complete.
DISTRIBUTION
Nebraska, Illinois, California, Iowa, Maryland, North Carolina,
Florida, South Dakota.
QUANTITY
a) 27; b) 3 units; c) 2 units; d) 5 units; e) 3 units; f) 7
units; g) 7 units; h) 8 units; i) 6 units; j) 25 units were
distributed.
REASON
Blood products tested negative for the antibody to the human
immunodeficiency virus (HIV), but were collected from donors who
previously tested reactive for the antibody, were distributed.
________
PRODUCT
Platelets, Pheresis. Recall #B-562-9.
CODE
Unit #R00607.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee,
Wisconsin.
RECALLED BY
Manufacturer, by telephone on February 2, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit was distributed.
REASON
Blood product had an unacceptable platelet count.
________
PRODUCT
Source Plasma. Recall #B-565-9.
CODE
Unit #62039611.
MANUFACTURER
Interstate Blood Bank, Inc., of Wisconsin, Milwaukee,
Wisconsin.
RECALLED BY
Manufacturer, by letter dated March 15, 1996. Firm-initiated
recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was not quarantined after receiving post donation
information regarding a history of hepatitis.
________
PRODUCT
Source Plasma. Recall #B-589-9.
CODE
Unit #74030149.
MANUFACTURER
Interstate Blood Bank Inc. of Wisconsin, Kenosha, Wisconsin.
RECALLED BY
Manufacturer, by fax on January 7, 1997. Firm-initiated recall
complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had a tattoo within
12 months of donation.
________
PRODUCT
Source Plasma. Recall #B-590-9.
CODE
Unit numbers: 91709271, 88989952, 88985985, 88984988, 88981239,
88980492, 88626086, 88622439, 88621616, 88803609, 88800523,
88448787.
MANUFACTURER
Interstate Blood Bank Inc. of Wisconsin, Kenosha, Wisconsin.
RECALLED BY
Manufacturer, by fax on December 26, 1997. Firm-initiated recall
complete.
DISTRIBUTION
California.
QUANTITY
12 units were distributed.
REASON
Blood products were collected from a donor who had previously
been deferred for an undocumented reason.
________
PRODUCT
Platelets, Pheresis. Recall #B-592-9.
CODE
Unit #0011645.
MANUFACTURER
The Community Blood Center, Inc., Appleton, Wisconsin.
RECALLED BY
Manufacturer, by letter dated March 24, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who failed to properly
respond to a high risk behavior question.
________
PRODUCT
Source Plasma. Recall #B-593-9.
CODE
Unit numbers: 74030323, 70659146, 70657012, 70655902.
MANUFACTURER
Interstate Blood Bank, Inc. of Wisconsin, Kenosha, Wisconsin.
RECALLED BY
Manufacturer, by fax on January 7, 1997. Firm-initiated recall
complete.
DISTRIBUTION
California.
QUANTITY
4 units were distributed.
REASON
Blood products were collected from a donor who had been
incarcerated.
________
PRODUCT
Source Plasma. Recall #B-594-9.
CODE
Unit #X016608.
MANUFACTURER
Community Bio-Resources, Green Bay, Wisconsin.
RECALLED BY
Manufacturer, by letter dated August 22, 1997. Firm-initiated
recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who was not asked any of
the pre-donation donor screening questions.
________
PRODUCT
Red Blood Cells. Recall #B-599-9.
CODE
Unit numbers: 40FW17730 and 40GS42681.
MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY
Manufacturer, by letter dated December 4, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Illinois and Massachusetts.
QUANTITY
2 units were distributed.
REASON
Blood products were collected from a donor who traveled to an
area considered endemic for malaria.
CODE
Unit #J06520.
MANUFACTURER
Central California Blood Center, Fresno, California.
RECALLED BY
Manufacturer, by letter or fax on June 10, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Virginia and California.
REASON
Blood products were which tested negative for the antibody to the
human immunodeficiency virus type 1 (HIV-1), but were collected
from a donor who previously tested repeatedly reactive for the
antibody, Western Blot negative.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-582/583-9.
CODE
Unit #42FX73919.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letter dated January 8, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Ohio and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had received
Heptavax within seven days of donation.
________
PRODUCT
Fresh Frozen Plasma. Recall #B-591-9.
CODE
Unit #KM11583.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee,
Wisconsin.
RECALLED BY
Manufacturer, by telephone on February 25, 1998, and by letter
dated March 2, 1998. Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit was distributed.
REASON
Blood product corresponded to a unit of red blood cells that were
positive for Propionibacterium acnes.
________
PRODUCT
Defibrillation Electrode Pads Model: Catalog # (p/n): 902402
Packed 1 box of 10 pair with Catalog #902400
Packed 1 box of 5 pair with Catalog #902401
Packed 1 box of 2 pair with Catalog #902404. Recall #Z-732-9.
CODE
All Lots. Part #/Catalog #: 902402 (electrodes).
The following part numbers represent the various packaging
configurations which contain the electrodes: 902400, 902401,
902404.
MANUFACTURER
Laerdal Medical Corporation, Wappingers Falls, New York.
RECALLED BY
Manufacturer, by letter dated February 11, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Norway.
QUANTITY
36,000 pair of electrodes were distributed.
REASON
The conductive gel on individual pads can deteriorate into a
liquid. Gel deterioration may occur to the extent the electrode
pad becomes unusable because it will not adhere to the patient
and will not provide adequate electrical contact.
_________
PRODUCT
Progesterone Reagent Microparticle Enzyme Immunoassay.
Recall #Z-734-9.
CODE
List No. 7A64-20, Lot Nos. 40868M300, EXP 2/21/99; 2623M200,
EXP 4/10/99; 43658M100, EXP 4/24/99; 44002M100, 2/21/99;
44524M200, EXP 5/23/99; 44870M200, EXP 6/30/99; 45085M100, EXP
8/5/99; 45436M300, EXP 8/19/99; 45878M200, EXP 2/21/99; and
48729M200, EXP 10/14/99.
MANUFACTURER
Abbott Laboratories, Abbott Park, Illinois.
RECALLED BY
Manufacturer, by letter on January 29, 1999. Firm-initaited
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
12,408 packs were distributed.
REASON
Product produces elevated calibrator rates and unacceptable
precision.
_______
UPDATE
The following statement is issued to clarify the responsiblity
issues involving recall Z-667/669-9 published in the Enforecemnt
Report for March 3, 1999:
The distribution and sale of Amvisc FB in the U.S. was an
independent action by World Optics. Neither Lifecore Medical,
Inc. nor Bausch & Lomb Surgical, Inc. had any involvement or
prior knowledge of the sales of Amvisc FB in the U.S.
CODE
Part No. 7355G for .55mm blade, Lot #98107614.
MANUFACTURER
Feather Safety Razor Company, Ltd., Osaka, Japan.
RECALLED BY
Oasis Medical, Glendora, California, by telephone on January 6,
7 and 15, 1999. Firm-initiated recall complete.
DISTRIBUTION
California, Indiana, Massachusetts, New Jersey, Ohio, Oklahoma,
South Carolina, Tennessee, West Virginia.
QUANTITY
40 boxes were distributed.
REASON
The scalpel handle is etched as a .35 mm scalpel instead of a .55
mm scalpel. The carton and box are labeled as being a .55 mm
scalpel.
CODE
Lot #1162 EXP 10-99.
MANUFACTURER
EVSCO, Buena, New Jersey.
RECALLED BY
Manufacturer, by stopping distribution for their warehouse
facilities in New Jersey and California on October 1, 1998, and
by fax on October 1-2, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
4,758 dozen were distributed.
REASON
Product is subpotent and failed assay tests for active
ingredients.
________
PRODUCT
a) Al Sherman High Mash Non-Medicated; b) Al Sherman Low Mash
Non-Medicated. Recall #V-040/041-9.
CODE
Manufacturing Date of 1/18/99.
MANUFACTURER
Poulin Grain, Newport, Vermont.
RECALLED BY
Manufacturer. A new shipment of Low Mash was delivered to the
farm on January 25, 1999. Tests were performed on a number of
cows and their milk after a few days. Tests were negative. The
High Mash was removed from the farm and replaced and a subsequent
delivery was replaced as part of customer relations. Firm-initiated recall complete.
DISTRIBUTION
New Hampshire.
QUANTITY
a) 24,170 pounds; b) 12,242 pounds were distributed.
REASON
High Mash and Low Mash are nonmedicated feed which were found to
contain chlortetracycline and sulfamethazine due to a
manufacturing error.
________
PRODUCT
Milk Fever 23% (for the treatment of milk fever in cattle and as
a nutritional supplement for bovine), 500 ml per bottle, under
the following brands: Radix Labs Sauk Prairie Veterinary Clinic,
Prairie du Sac, WI; Town & Country Veterinary Service, Stratford,
WI; AgriLabs Calcium Gluconate 23% Solution Sterile, St Joseph,
MO (labeled as a sterile source of calcium and other electrolytes
with dextrose for treating milk fever in cattle); Pro Labs
C-M-P-K Injection (labeled as a treatment of hypocalcemia,
hypomagnesium and other conditions):
a) (Radix Milk Fever 23%); b) (Agri Labs Calcium Gluconate 23%);
c) (Radix Labs CMPK); d) (Pro Labs C-M-P-K Injection).
Recall #V-043/046-9.
CODE
Lot numbers : R7N001 - Milk Fever 23%
R7L018 - Agri Labs Calcium Gluconate 23%
R7N008 - Radix Labs and Pro Labs CMPK.
MANUFACTURER
Radix Laboratories, Inc.,. Eau Claire, Wisconsin.
RECALLED BY
Manufacturer, by letter dated March 4, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Iowa, Minnesota, Missouri, New York, Pennsylvania, California,
Massachusetts, Texas, Wisconsin.
QUANTITY
14,140 500-ml bottles of Milk Fever 23% and Agri Labs Calcium
Gluconate; 7,060 500-ml bottles of CMPK were distributed.
REASON
Precipitate found in the injectable product at 18 month check
(product has 2 year expiration dating).
CODE
Lot #R6L011.
MANUFACTURER
Radix Laboratories, Inc., Eau Claire, Wisconsin.
RECALLED BY
Manufacturer, by letter dated March 8, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Iowa, Kansas, Minnesota, Missouri, Texas.
QUANTITY
672 100-ml bottles were distributed.
REASON
Precipitate found in the injectable product at 18 month check
(product has 2 year expiration dating.