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.
ENFORCE
09/01/1993
Recalls and Field Corrections: Foods -- Class I -- 09/01/1993
SEPTEMBER 1, 1993 93-35
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
=========================
_______________
PRODUCT Soyagen, Soy Beverage Powders: (a) Soyagen, All Purpose in 3.5
pound cans and 14 ounce cans (b) Soyagen, No Sucrose in 3.5
pound cans and 14 ounce cans (c) Soyagen Carob Flavor in 3.5
pound cans and 14 ounce cans. Products spray dried and/or
packaged since November 4, 1992. Recall #F-496/498-3.
CODE All products with day codes of 2338 or larger.
MANUFACTURER Maple Island, Inc., Wanamingo, Minnesota (spray/dried).
RECALLED BY Worthington Foods, Inc., Worthington, Ohio, by letter June
30, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Martinique, Guyana, French West Indies, Virgin
Islands, Canada, Antilles, Bermuda.
QUANTITY (a) 6,677, (b) 5,688, (c) 4,339 cases were distributed.
REASON The products were manufactured under conditions in which they
may have become contaminated by Salmonella.
_______________
PRODUCT La Choy Beef Pepper Oriental BI-PACK- Dinner, consisting of a
14 ounce can of beef gravy, 42 ounce can of oriental vegetable
mix and seasonings. Recall #F-614-3.
CODE Embossed on top of cans: 33R01, 34604 (bi-pak); 347Y1, 347Y2
vegetable mix can codes (not readily visible).
MANUFACTURER La Choy/Rosarita Foods Company, Archbold, Ohio.
RECALLED BY Hunt-Wesson, Inc., Fullerton, California, by letter May 7,
1993. Firm-initiated recall complete.
DISTRIBUTION Illinois, Indiana, Missouri, Ohio, Texas, Wisconsin.
QUANTITY 303 cases were distributed.
REASON The product has the potential to support the growth of
Clostridium botulinum toxin.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
========================
________________
PRODUCT Various flavors of popcorn packaged in 3.5 ounce and 4 ounce
poly bags: (a) Caramel Flavored Popcorn;
(b) Low-Cal Caramel Flavored Popcorn;
(c) Vanilla Flavored Popcorn;
(d) Low-Cal Vanilla Flavored Popcorn;
(e) Red-Cinnamon Flavored Popcorn;
(f) Low-Cal Cinnamon Flavored Popcorn;
(g) Rainbow Flavored Popcorn;
(h) Buttered Rum Flavored Popcorn;
(i) Amaretto Flavored Popcorn;
(j) Pina Colada Flavored Popcorn;
(k) Butterscotch Flavored Popcorn;
(l) Toffee Flavored Popcorn;
(m) Maple Flavored Popcorn. Recall #F-590/602-3.
CODE All lots.
MANUFACTURER Twin Valley Developmental Services, Inc., Greenleaf, Kansas.
RECALLED BY Manufacturer, by letter dated May 3, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Kansas, Michigan, Wisconsin, South Dakota.
QUANTITY Approximately 1,600 bags of popcorn were distributed.
REASON Products contain undeclared FD&C Yellow No. 5.
-2-
_______________
PRODUCT Bison Astro Lowfat Yogurt, in 4.4 ounce plastic cups:
(a) Mixed Berry Crunch; (b) Pecan Toffee Crunch;
(c) Apple Crisp Granola; (d) Oat Bran Raisin Granola.
Recall #F-603/606-3.
CODE All code dates up to and including JUL 93.
MANUFACTURER Imperial Flavors, Inc., Ontario, Canada (supplier of bulk
crunch and granola).
RECALLED BY Bison Foods Company, Division Upstate Milk Cooperatives, Inc.,
Buffalo, New York, by telephone and letter June 10 and 11,
1993. Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Pennsylvania, Connecticut, Maryland,
Virginia, Vermont, Rhode Island, Michigan, Washington, D.C.
QUANTITY (a) 7,283 cases; (b) 5,773 cases; (c) 9,944 cases; (d) 8,373
cases were distributed; firm estimates 50 percent of product
remains on the market.
REASON Products contain undeclared FD&C Yellow No. 5.
_______________
PRODUCT Bison Astro Chocolate Fudge Crunch Lowfat Yogurt, in 4.4 ounce
plastic cups. Recall #F-607-3.
CODE All codes up to and including AUG 8.
MANUFACTURER Imperial Flavors, Inc., Ontario, Canada (supplier of bulk
crunch and granola).
RECALLED BY Bison Foods Company, Division Upstate Milk Cooperatives, Inc.,
Buffalo, New York, by telephone and letter June 10 and 11,
1993. Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Pennsylvania, Connecticut, Maryland,
Virginia, Vermont, Rhode Island, Michigan, Washington, D.C.
QUANTITY 5,210 cases were distributed; firm estimates 20 percent of
product remains on the market.
REASON Product contains undeclared FD&C Red #2, Red #40, and Blue #1.
_______________
PRODUCT Bison Astro Peanut Butter Crunch Lowfat Yogurt, in 4.4 ounce
plastic cups. Recall #F-608-3.
CODE All codes up to and including AUG 8.
MANUFACTURER Imperial Flavors, Inc., Ontario, Canada (supplier of bulk
crunch and granola).
RECALLED BY Bison Foods Company, Division Upstate Milk Cooperatives, Inc.,
Buffalo, New York, by telephone and letter June 10 and 11,
1993. Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Pennsylvania, Connecticut, Maryland,
Virginia, Vermont, Rhode Island, Michigan, Washington, D.C.
QUANTITY 4,680 cases were distributed; firm estimates 20 percent
remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5 and Red No. 40.
-3-
_______________
PRODUCT Immusyn-C and NCHF Nu Cell Herbal Formula, 100 capsules per
bottle. Recall #F-611-3.
CODE None.
MANUFACTURER Olan Laboratories Inc./Prominance S.A., Brentwood, New York.
RECALLED BY Manufacturer by letter June 28, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Mexico.
QUANTITY 224,430 capsules were distributed.
REASON Product contains calamus root, substance prohibited from use
in human food.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
=======================
_______________
PRODUCT Canned Tomato Puree, in 28 ounce cans.
Recall #F-575-3.
CODE _____4 over TPCX (2 lines).
MANUFACTURER Rokeach Food Corporation, Newark, New Jersey.
RECALLED BY Manufacturer by telephone April 1, 1993, and letter April 19,
1993. Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, New York, Pennsylvania, Florida, Massachusetts,
Rhode Island, Vermont, Maine.
QUANTITY 6,742 cases were distributed. Firm estimates 2,000 to 2,500
remain on market.
REASON Product is contained in swollen cans.
_______________
PRODUCT Homestead Natural Mountain Spring Water, in 50.7 fluid ounce
plastic bottles. Recall #F-576-3.
CODE "001BS50713______"series lot number (the last five digits vary
with production line and time of production).
MANUFACTURER A. Smith Bowman Distillery, Fredericksburg, Virginia.
RECALLED BY Bath Springs Water, Inc., Arlington, Virginia, by letter on or
about July 6, 1993. Firm initiated recall ongoing.
DISTRIBUTION Virginia, Maryland, North Carolina, South Carolinia, Florida,
Tennessee, Texas.
QUANTITY 2,095 cases; (12/1.5L bottles per case) were distributed.
REASON Product is contaminated with mold.
-4-
______________
PRODUCT Smokey Phil's Salmon Jerky, individually vacuum packed, 18
pieces/container. Recall #F-585-3.
CODE None.
MANUFACTURER Smokey Phil's Specialty Foods, Malad City, Idaho.
RECALLED BY Manufacturer by visit July 13, 1993. Firm-initiated recall
complete.
DISTRIBUTION Utah.
QUANTITY Approximately 22 containers were distributed.
REASON Product is contaminated with surface mold.
_______________
PRODUCT Premium Blue Lake Cut Green Beans in 16 ounce metal cans.
Recall #F-586-3.
CODE 613 M/4K21 embossed into can end.
MANUFACTURER American Fine Foods Inc., Milton Freewater, Oregon.
RECALLED BY American Fine Foods Inc., Payette, Idaho, by memorandum June
17, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Washington state, California.
QUANTITY 429 cases were distributed.
REASON Product is contained in swollen containers
_______________
PRODUCT Brick House Spring Water All-Natural in 1 gallon containers.
Recall #F-587-3.
CODE 020895.
MANUFACTURER Brick House Farm Water Company, Ellicott City, Maryland.
RECALLED BY Manufacturer by owner on or about May 14, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Maryland, Virginia.
QUANITY 7,140\1 gallon containers manufactured; 3,660 distributed;
3,480 remain on market.
REASON Product has an off-odor.
_______________
PRODUCT (a) QF Brand Tail Off Breaded Shrimp in 8 ounce basket; (b) QF
& Gulf Mex Brands Tail On Breaded Shrimp in 8 ounce basket.
Recall #F-588/589-3.
CODE (a) x0203, x0773, x0953, x1053, (b) X0953 where x is a
valuable number, 1-4, representing packaging shift.
MANUFACTURER QF Inc., Bayou La Batre, Alabama.
RECALLED BY Manufacturer by telephone June 23, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION California, Utah, Wisconsin.
QUANTITY (a) 675 cases; (b) 229 cases were distributed.
REASON Product is overbreaded.
-5-
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
_______________
PRODUCT Hydrochlorothiazide tablets, 25 mg, bottles of 100, an oral Rx
diuretic tablet. Recall #D-326-3.
CODE Lot numbers 2089-401, exp. date 1/95.
MANUFACTURER Zenith Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Manufacturer by phone on or about March 25, 1993. Firm-
initiated recall complete.
DISTRIBUTION Connecticut.
QUANTITY 144 bottles were distributed.
REASON Bottles of 50 mg tablets were mislabeled as 25 mg.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Amberline brand Orphedral AD Tablets, an OTC decongestant
product. Recall #D-323-3.
CODE Lot #023038, exp. date 7/95.
MANUFACTURER Contract Pharmacal, Hauppauge, New York.
RECALLED BY Moore Medical Corporation, New Britain, Connecticut, by letter
August 13, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico.
QUANTITY 1,871 packages/24 tablets were distributed.
REASON Product bears incorrect expiration date of 7/95 instead of
8/94.
_______________
PRODUCT Quinine Sulfate Capsules, USP 325 mg, in bottles of 1,000, an
OTC drug used in the treatment of malaria. Recall #D-324-3.
CODE Lot #2H005 EXP 12/94.
MANUFACTURER EON Labs Manufacturing, Inc., Laurelton, New York.
RECALLED BY Manufacturer, by telephone and by letter August 9, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersy, Florida.
QUANTITY 47 bottles were distributed.
REASON Capsules imprinted with old logo "PP" were labeled with new
label declaring new logo "E".
______________
PRODUCT Piercing Pagoda's Ear Care Antiseptic Solution in 4 fluid
ounce plastic bottles. Recall #D-325-3.
-6-
CODE Lot numbers: 030493, 030393, 030293, 390140, 399040, 398040,
397040, 396040, 390150, 399050, 398050, 397050, 396050,
396160, 398060, 399060, 390160, 391160, 391070, 392070,
393070, 394070, 395070, 390180, 399080, 398080, 397080,
396080.
MANUFACTURER EMS Contract Packaging, Fort Washington, Pennsylvania.
RECALLED BY Piercing Pagoda, Bethlehem, Pennsylvania, by letter August 16,
1993. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 169,359 units were distributed.
REASON Label lacks an ingredient statement.
_______________
PRODUCT (a) PSOR-A-SET Lotion, an OTC product, in 4 ounce and 8 ounce
bottles,
(b) PSOR-A-SET Soap Bars in 3.25 oz. bars, used for relief of
psoriasis of the skin. Recall #D-327/328-3.
CODE (a) Lot #'s E169 exp. date 3/91; 170 exp. date 3/91; E171 exp.
date 3/91; E172 exp. date 3/91; E173 exp. date 3/91; E197 exp.
3/91; E578 exp. date 6/91; F046 exp. date 11/91; F047 exp.
11/91; F048 exp. date 11/91; F108 exp. date 11/91, (b) 3079
(no exp. date).
MANUFACTURER Topiderm Inc., Bohemia, New York.
RECALLED BY Tosti-Life Inc., Bohemia, New York, by letter July 7, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY (a) 10,000 bottles, (b) 15,000 bars were distributed.
REASON (a) Expiration date extended two additional years without
stability data; (b) Product lacks stability testing.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
====================
_______________
PRODUCT (a) Human Serum, Pooled; (b) Recovered Plasma, Pooled, Recall
#B-387/388-3
CODE: Pool numbers: (a)85RB0412-1, 85RB1115-1, 85RB1118-1,
85RB1612-1, 85RB1811-2, 85RB2312-1, 86RB0112-1, 86RB0205-1,
86RB0206-1, 86RB0209-1, 86RB0302-1, 86RB0307-1, 86RB0409-1,
86RB0505-1, 86RB0512-1, 86RB0606-1, 86RB0610-1, 86RB0704-1,
86RB0704-2, 86RB0707-2, 86RB0901-1, 86RB0906-1, 86RB1306-1,
86RB1403-1, 86RB1411-1, 86RB1505-1, 86RB1509-1, 86RB1512-1,
86RB1601-1, 86RB1804-1, 86RB1807-1, 86RB1902-1, 86RB1905-1,
86RB1909-1, 86RB1911-1, 86RB2003-1, 86RB2006-1, 86RB2008-1,
86RB2011-1, 86RB2108-1, 86RB2209-1, 86RB2210-1, 86RB2212-1,
86RB2307-1, 86RB2401-1, 86RB2410-1, 86RB2411-1, 86RB2504-1,
86RB2506-1, 86RB2508-1, 86RB2509-1, 86RB2511-1, 86RB2605-1,
86RB2609-1, 86RB2701-1, 86RB2705-1, 86RB2706-1, 86RB2802-1,
86RB2807-1, 86RB2808-1, 86RB2810-1, 86RB2901-1, 86RB3004-1,
86RB3103-2, 86RB3112-1, 87RB0202-1, 87RB0303-1, 87RB0312-1,
-7- 87RB0406-1, 87RB0409-1, 87RB0506-1, 87RB0510-1, 87RB0510-2,
87RB0607-1, 87RB0608-1, 87RB0801-1, 87RB0804-1, 87RB0910-1,
87RB1008-1, 87RB1108-1, 87RB1303-1, 87RB1304-1, 87RB1405-1,
87RB1509-1, 87RB1601-1, 87RB1602-1, 87RB1603-1, 87RB1604-1,
87RB1607-1, 87RB1610-2, 87RB1611-1, 87RB1702-1, 87RB1805-1,
87RB1809-1, 87RB1809-2, 87RB1812-1, 87RB1902-1, 87RB1903-1,
87RB1906-1, 87RB2109-1, 87RB2112-1, 87RB2112-2, 87RB2307-1,
87RB2310-1, 87RB2407-2, 87RB2601-1, 87RB2605-1, 87RB2608-1,
87RB2703-1, 87RB2704-1, 87RB2801-1, 87RB2805-1, 87RB3003-1,
87RB3007-1, 87RB3009-1, 87RB3011-2, 87RB3103-1, 87RB3108-2,
88RB0107-1, 88RB0402-1, 88RB0410-1, 88RB0411-1, 88RB0512-1,
88RB0707-1, 88RB0711-1, 88RB0804-1, 88RB0909-1, 88RB1006-1,
88RB1011-1, 88RB1102-1, 88RB1108-1, 88RB1111-1, 88RB1212-1,
88RB1410-1, 88RB1504-1, 88RB1509-1, 88RB1802-1, 88RB1804-2,
88RB1805-1, 88RB1807-1, 88RB2203-1, 88RB2312-1, 88RB2406-1,
88RB2504-1, 88RB2507-1, 88RB2510-1, 88RB2610-1, 88RB2705-1,
88RB2706-1, 88RB2801-1, 88RB2901-1, 88RB2908-1, 88RB3005-1,
89RB0211-1, 89RB0301-1, 89RB0311-1, 89RB0501-1, 89RB0607-1,
89RB0704-1, 89RB0711-1, 89RB0805-1, 89RB1007-1, 89RB1105-1,
89RB1108-1, 89RB1201-1, 89RB1301-1, 89RB1408-1, 89RB1502-1,
89RB1603-1, 89RB1706-1, 89RB1711-1, 89RB2206-2, 89RB2212-1,
89RB2403-1, 89RB2610-1, 89RB2702-1, 89RB2702-2, 89RB2907-1,
89RB2804-1, 89RB2909-1, 89RB3011-1, 89RB3012-1, 90RB0106-1,
90RB0211-1, 90RB03013, 90RB03014 , 90RB3017, 90RB03022,
90RB0901-1, 90RB0906-1, 90RB1011-1, 90RB1101-2, 90RB1110-1,
90RB1201-1, 90RB1210-1, 90RB1307-1, 90RB1407-1, 90RB1510-1,
90RB1709-1, 90RB1808-1, 90RB1906-1, 90RB1910-1, 90RB2009-1,
90RB2308-1, 90RB2806-1, 90RB2901-1, 90RB3105-1, 91RB03002,
91RB03011, 91RB03021, 91RB03024, 91RB03025,
91RB03031, 91RB03047, 91RB03048, 91RB03061, 91RB03068,
91RB03077, 91RB03079, 91RB03083, 91RB03086, 91RB03091,
91RB03097, 91RB03099, 91RB03111, 91RB03115, 91RB03120,
91RB03130, 91RB03146, 91RB03148, 91RB03157, 91RB03159,
91RB03162, 91RB03163, 91RB03179, 91RB03184, 91RB03185,
92RB3002, 92RB3007, 92RB3010, 92RB3026, 92RB3068, 92RB3085,
92RB3086, 92RB3413, 92RB3432, 92RB3449, 92RB3450, 92RB3469,
92RB3475, 92RB3499, 92RB3519, 92RB3520, 92RB3537, 92RB3540
(b) Recovered Plasma, Pooled numbers: 89RB0805-1, 89RB1105-1,
90RB0612-1, 90RB1012-1, 90RB1312-1, 90RB1709-1, 90RB1909-1,
90RB2008-1, 90RB2408-1, 90RB2412-1, 90RB3108-1, 91RB0501-1.
MANUFACTURER American Red Cross Blood Services, Buffalo, New York.
RECALLED BY Manufacturer, by letter May 18, 1993. Firm-initiated recall
complete.
DISTRIBUTION Massachusetts.
QUANTITY (a) 255 units; (b) 12 units were distributed.
REASON Pooled blood products, which contained one or more units that
tested negative for the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), but were collected from donors who
previously tested repeatedly reactive for anti-HIV-1, were
distributed.
-8-
_______________
PRODUCT Red Blood Cells. Recall #B-390-3.
CODE Unit #15039-2643.
MANUFACTURER United Blood Services, Lubbock, Texas.
RECALLED BY Manufacturer, by visit July 10, 1993. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY One unit was distributed.
REASON Product which tested negative for antibody to human
immunodeficiency virus type I (anti-HIV-I) but was collected
from a donor who previously tested repeatedly reactive for
anti-HIV-I, was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Source Plasma. Recall #B-378-3.
CODE Unit #R61148.
MANUFACTURER Walter L. Shepeard Community Blood Center, Augusta, Georgia.
RECALLED BY Manufacturer, by letter April 1, 1993. Firm-initiated recall
complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit.
REASON An unlicensed blood product, which was improperly labelled,
was distributed in interstate commerce.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Recovered Plasma,
Recall #B-379/381-3.
CODE (a) TP0603759; (b) MI0006213, LC01436, LC01754, NP0500948,
OR0704766, (c) LC00120, MI0004171, MI0004227.
MANUFACTURER Personal Blood Storage of America (LC Prefix), Charlotte,
North Carolina; Personal Blood Storage of Miami (MI), Miami,
Florida; Personal Blood Storage of America (NP), Columbia,
South Carolina; Personal Blood Storage of Orlando, Inc. (OR),
Orlando, Florida; Personal Blood Storage of Orlando, (TP)
Tampa, Florida.
RECALLED BY Personal Blood Storage of Memphis, Inc., Memphis, Tennessee,
by telephone April 7, 1993. Firm-initiated recall complete.
DISTRIBUTION South Carolina, North Carolina, Florida.
QUANTITY (a) 1 unit; (b) 5 units; (c) 3 units were distributed.
REASON Blood products, which were improperly tested for the antibody
to Hepatitis B Core antigen (anti-HBc), antibody to Hepatitis
C Virus (anti-HCV), and antibody to the Human T-Lymphotropic
Virus Type I (anti-HTLV-I) were distributed.
-9- _______________
PRODUCT Red Blood Cells. Recall #B-389-3
CODE Unit #LM38085, LM38607, LM38739, LM38754.
MANUFACTURER San Diego Blood Bank, San Diego, California.
RECALLED BY Manufacturer by letter April 26, 1993. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 4 units were distributed.
REASON Blood products collected in Anticoagulant Citrate Phosphate
Dextrose Adenine Solution (CPDA-1) bags that exceeded their
expiration date were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT S & W Model 9215 Arrhythmia Plug-in Modules, Recall
#Z-725-3.
CODE Serial numbers: 10283963, 10295762, 10298116, 10298117,
10299985, 10299992.
MANUFACTURER S & W Medico Teknik A/S, Denmark.
RECALLED BY Narco Medical Services, Inc., Minneapolis, Minnesota, by
telephone June 21, 1993. Firm-initiated recall ongoing.
DISTRIBITION Missouri.
QUANTITY 12 units were distributed.
REASON The ventricular fibrillation could go undetected if there is
AvR lead configuration on channel I of the device; normal ECG
rhythms greater than 160 beats/minute resulted in false
positive detection of ventribular fibrillation; and,
instability of the heart rate display in certain circumstances
of high heart rate (between 220 and 300 beats/minute which
resulted in a VFIB alarm.
-10-
####