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
07/09/1991
FDA Enforcement for the week of 7/10/91
FDA ENFORCEMENT REPORT
FOR JULY 10, 1991
July 10, 1991
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
Product: Various crabmeat products:
(a) Cocktail Claws, Item #209901, in 1 kg packages,
under RAS label, Item #209918 in 20 pound packages,
under Capecod label;
(b) Chunk Legmeat, Item 209902, in 5 pound packages,
under Capecod label;
(c) Scored Claws, Item #2099903, in 1 kg packages, under
FEINFR label, Item #209905, in 12 ounce packages under
Capecod label, Item 209910, in 1 pound packages, under
Capecod label, Item #209917, in 20 pound packages, under
Capecod label;
(d) Salad Meat, Item #209904, in 5 pound packages under
Capecod label, Item #209906, in 16 pound packages, under
Capecod label;
-1-
(e) Rice Meat, Item #209907 in 16 pound packages, under
Capecod label;
(f) IQF In-Shell Legs 6 CM-UP, Item #209908, in 22 pound
packages, under TON label;
(g) Scored Claws Size S, Item #209911 in 1 kg packages,
and Item #209919, in 300 gr packages, under RAS label;
(h) Retail Meat, Item 209912, in 6 ounce packages,
under Capecod label;
(i) IQF In-Shell Legs Top Joint, Item 209914, in 22
pound packages under TON label;
(j) IQF In-Shell Legs 5-6 cm, Item #209915, in 22 pound
packages under TON label;
(k) Red Crab Rice Bulk, Item 209916, in 16 pound packages,
under Capecod label;
(l) Whole Fany Claws, Item #209920, in 22 pound packages,
under TON label;
(m) Scored Claws Size M, Item 209921, in 1 kg packages,
under RAS label;
(n) Scored Claws Size L, 209922, in 1 kg packages,
under RAS label;
(o) Scored Claws Size LL, Item #209923, in 1 kg packages,
under RAS label;
(p) MCD Crabmeat, Item #209926, in 16 pound packages,
under TON label;
(q) Scored Claws Size XLL, Item209928, in 1 kg packages,
under RAS label. Recall #F-467/483-1.
Code: All lots.
Manufacturer: Waco, Inc., Danvers, Massachusetts.
Recalled by: Bay Trading Company, Inc., Danvers, Massachusetts by
telephone May 16-17, 1991. Firm-initiated recall ongoing.
Distribution: Illinois, Rhode Island, Massachusetts, Florida, New York,
New Jersey, Virginia, Ohio, California, Minnesota, Maryland,
Japan, Germany.
Quantity: (a) 10; (b) 6; (c) 35; (d) 6; (e) 4; (f) 1; (g) 6;
(h) 12; (i) 1; (j) 1; (k) 4; (l) 1; (m) 1; (n) 6;
(o) 6; (p) 6; (q) 3; (r) 6 packages were distributed.
Reason: Products contain undeclared sulfite at levels greater
than 10 mg per serving.
----
Product: Kay's Ice cream novelties/frozen yogurt novelties,
fruit flavored ices, and ice cream products:
(a) Deluxe Fudge Bars, 6's and 30's;
(b) Krunch Bars, 6's and 24's;
(c) Moo Cow Bars, 6's and 30's
(d) Toffee Bars, 6's and 24's;
(e) Cookies and Cream Bars, 6's and 30's;
(f) Cream'N Orange Bars, 6's and 30's;
(g) Peach frozen Yogurt Bars, 6's and 30's;
(h) Strawberry Frozen Yogurt Bars, 6's and 30's;
(i) Assorted Twin Treats, 12's, (cherry, grape and
orange flavors);
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(j) Banana Twin Treats (pops), 6's and 24's;
(k) Cherry Twin Treats (pops), 6's and 24's;
(l) Grape Twin Treats (pops), 6's and 24's;
(m) Orange Twin Treats (pops), 6's and 24's;
(n) Cookies and Cream Ice Cream Half Gallon.
Recall #F-451/464-1.
Code: All lots.
Manufacturer: Kay's Ice Cream of Knoxville, Inc., Knoxville, Tennessee.
Recalled by: Manufacturer, by telephone May 7, 1991, by visit
beginning May 8, 1991 and by letter May 14, 1991.
Firm-initiated recall ongoing.
Distribution: Alabama, Georgia, Kentucky, Tennessee, Virginia,
West Virginia.
Quantity: Unknown.
Reason: Products contaminated with Listeria monocytogenes.
----
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Various food products:
(a) Turnover Shells; (b) Cheese Turnover Shells;
(c) Guava Turnover Shells; (d) Meat Turnover Shells;
(e) Pizza Turnover Shells, net weight 8 ounces.
Recall #F-445/449-1.
Code: None.
Manufacturer: Miguel Montero Inc., Hato Rey, Puerto Rico.
Recalled by: Manufacturer, by placing stickers on the products
beginning February 14, 1991. Firm-initiated field
correction ongoing.
Distribution: Puerto Rico.
Quantity: Firm estimates 150 (24 units/case) remain on the market.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Bottled Water in 12 fluid ounce plastic bottles
(24 per case) and in 1.5 liter plastic bottles
(12 per case). Recall #F-450-1.
Code: All lots repacked by bottler.
Note: The bottles and labels are similar to the
product bottled by another bottler. The product under
recall may be identified by having a blue label, instead
of a purple label, and having a label notch code,
instead of the code printed on the cap.
Manufacturer: Famous Ramona Water Company, Ramona, California (bottler).
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Recalled by: Island Waters Division, Aqua Vie Beverage Corporation
(Kauai Water Co./KWC), Hanalei, Kauai, Hawaii.
by letter April 17, 1990. Hawaii Department of Health
issued press release dated April 17, 1990. Firm-initiated
recall ongoing.
Distribution: Hawaii, California.
Quantity: Approximately 13,621 cases.
Reason: Product is contaminated with algae and Pseudomonas
Aeruginosa.
----
Product: Syrup Filled Wax Bottle, 5 ounces. The candy product
is a wax molded bottle containing a flavored syrup.
Recall #F-466-1.
Code: None.
Manufacturer: Glenn Confection Division, Buffalo, New York.
Recalled by: Snack World, Inc., Reading, Pennsylvania, by visit
beginning May 14, 1991. Firm-initiated field correction
ongoing.
Distribution: Pennsylvania.
Quantity: Unknown. Firm estimates very little if any mislabeled
product remains on the market.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Nutcracker brand salted large Cashew Pieces, in 17
ounce cans. Recall #F-465-1.
Code: Item #480, Lot numbers: 7770, 7890, 7897, 7898, 7911, 7912,
7922, 7923, 7926, 7927, 7929, 7933, 7932, 7934, 7937, 7938,
7939, 7948, 7947, 7950, 7952, 7953, 7955, 7957, 7958, 7959,
7960, 7963, 7964, 7965, 7966, 7967, 7968, 7971, 7970, 7977.
Can code, embossed: 0353, 0393, 0423, 0433, 0493, 0503, 0513,
0523, 0573, 0583, 0593, 0603, 0633, 0643, 0653, 0713, 0723,
0733, 0743, 0773, 0803, 0813, 0843, 0863, 0873, 0883, 0913,
0923, 0933, 0943, 0953.
Manufacturer: Nutcracker Snacks Inc., Billerica, Massachusetts.
Recalled by: Manufacturer, by telephone May 10, 1991 followed by
letter May 13, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 26,418 cartons (24 cans/case) were distributed.
Reason: Product contains quartz like material.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
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COSMETICS
Class I-
NONE
Class II -
Product: Gillette Epic Waves Home Permanents:
(a) Try-On Home Permanent;
(b) Anytime Home Permanent;
(c) Adaptable Home Permanent. Recall #F-442/444-1.
Code: All product produced prior to July 1990.
Manufacturer: The Gillette Company, Inc., St. Paul, Minnesota.
Recalled by: The Gillette Company, Inc., Boston, Massachusetts, by
reworking product beginning in November 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 3.4 million units were distributed;
firm estimates a small amount of product to remain on
the market.
Reason: When used as directed, the product causes an excessive
number of eye injuries.
----
Class III -
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Propranolol HCl Tablets, USP, (a) 40 mg/25 mg;
(b) 80 mg/25 mg, an Rx drug used for the management of
hypertension, in bottles of 100, 500 and 1,000, under the
Aligen, Duramed, Major, Parmed, Qualitest, Rugby and URL
labels. Recall #D-482/483-1.
Code: Lot numbers: (a) 91126, 91824, 91825 with EXP dates
ranging from 4/92 to 6/92;
(b) 91140, 91823 with EXP dates ranging from 4/92 to 6/92.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by letter May 22, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Approximately (a) 630,000 tablets; (b) 415,000 tablets
were distributed.
Reason: Products were not manufactured in accordance with
Abbreviated New Drug Application specifications.
----
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Product: Chlorzoxazone 250 mg Tablets in bottles of 100, 500,
and 1000 tablets, an Rx relaxant under the Pioneer,
Goldline, Quality Research Pharmaceuticals, Deliz
Pharmaceuticals and International Ethical Labs labels.
Recall #D-485-1.
Code: All lots (6012-4 through 6012-12).
Manufacturer: Pioneer Pharmaceuticals, Irvington, New Jersey.
Recalled by: Manufacturer, by letter April 24, 1991. Firm-initiated
recall ongoing.
Distribution: Arizona, California, Florida, Georgia, Indiana, Kentucky,
Michigan, Missouri, New Jersey, Ohio, Oklahoma,
Pennsylvania, South Carolina, South Dakota, Tennessee,
Virginia, Puerto Rico.
Quantity: Approximately 9 million tablets were distributed.
Reason: Product made with unapproved manufacturing change.
----
Product: Clorazepate Dipotassium Oral Tablets, in 3.75;
(b) 7.5 mg, in bottles of 100 and 500 tablets, and
(c) 15 mg in bottles of 100 tablets, an Rx drug used in the
management of anxiety and partial seizures, under the
Purepac, Schein, and Parmed labels. Recall #D-488/490-1.
Code: All lot numbers manufactured between 10/89 and 4/91.
Manufacturer: Purepac Pharmaceuticals, Elizabeth, New Jersey.
Recalled by: Manufacturer, by letter May 7, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and Puerto Rico.
Quantity: (a) 33,845 (100's), 3,940 (500's); (b) 44,916 (100's),
12,484 (500's); (c) 11,895 (100's) were distributed.
Reason: Some lots fail dissolution specifications. Others lack
assurance of meeting specifications through expiration
date.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Platelets, Pheresis; (e) Recovered Plasma.
Recall #B-324/328-1.
Code: Unit numbers: (a) 32M83460, 32M83484, 32M83485,
32M84367, 32M85202, 32M85177, 32M85325, 32M85867,
32FS00950, 32FS00963, 32FS01413, 32FS01479, 32FS01558,
32FS01578, 32FS01592, 32FS01968, 32FS01972, 32FS07358,
32FS07363, 32FS07364, 32FS07375, 32FS07384;
(b) 32M83460, 32M84367, 32M85202, 32M85177, 32M85325,
32M85867, 32FS00963, 32FS01479, 32FS01968, 32FS01972,
32FS07358, 32FS07364, 32FS07384;
(c) 32FS00950, 32FS01413, 32FS01578, 32FS01592, 32FS07375;
(d) 32P39751, 32P39766;
(e) 32M83460, 32M83484, 32M83485, 32M84367, 32M85202,
32M85177, 32M85325, 32M85867, 32FS00950, 32FS00963,
32FS01413, 32FS01479, 32FS01558, 32FS01578, 32FS01592,
32FS01968, 32FS01972, 32FS07358, 32FS07363, 32FS07364,
32FS07375, 32FS07384.
-6-
Manufacturer: American Red Cross Blood Services, Green Bay, Wisconsin.
Recalled by: Manufacturer, by telephone April 15, 1991 and by
letter April 25, 1991. Firm-initiated recall ongoing.
Distribution: Wisconsin, Illinois, Iowa, Michigan, New Jersey, Texas,
Arkansas, Pennsylvania, South Carolina, Massachusetts,
California, Switzerland.
Quantity: (a) 22 units; (b) 13 units; (c) 5 units; (d) 2 units;
(e) 22 units.
Reason: Blood products, tested for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1) in a manner not
consistent with the manufacturer's test kit
instructions, were distributed.
----
Class III -
Product: Pediapred Oral Liquid (prednisolone sodium phosphate USP),
1 ounce and 4 ounce containers, a corticoid steroid
drug. Recall #D-484-1.
Code: All lot numbers beginning with M or N.
Manufacturer: Fisons Corporation, Rochester, New York.
Recalled by: Manufacturer, by letter May 1, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 53,500 units were distributed.
Reason: A lack of assurance that the raw material, prednisolone
sodium phosphate meets USP specifications.
----
Product: Duphalac (Lactulose Syrup USP), in 8, 16, and 32 fluid
ounce bottles, used for the treatment of constipation.
Recall #D-486-1.
Code: Lot numbers: 50324, 50325, 50326, 50327 (16 ounces);
50347, 50348, 50349 (32 ounces); 50350 (8 ounces).
Manufacturer: Reid-Rowell, Marietta, Georgia.
Recalled by: Manufacturer, by letter July 6, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates none remains on the market.
Reason: Presence of mold.
----
Product: Dopamine HCl Crystals USP, a bulk chemical entity, in
crystalline form, packaged in double bagged, fiberboard
and metal containers containing 55 pounds, a biosynthetic
precursor of noradrenaline, a sympathomimetic catecholamine.
The product is to be used for further manufacturing.
Recall #D-487-1.
Code: Lot $01861.
Manufacturer: Knoll Ag, Republic of Germany.
-7-
Recalled by: BASF Corporation, Wyandotte, Michigan, by letter dated
May 6, 1991. Firm-initiated recall complete.
Distribution: Illinois, California, Puerto Rico.
Quantity: 10 drums were distributed.
Reason: Adulterated with particles of paper.
----
Product: Nilstat Nystatin Powder, USP for extemporaneous
preparation of oral suspension, (a) 1 billion units;
(b) 2 billion units, an Rx drug used for the treatment of
intestinal and oral cavity infections caused by
Candida Albicans. Recall #D-491/492-1.
Code: Lot numbers: (a) D253-473, D274-484, D286-184, D288-171,
D294-149; (b) D250-435, D257-304, D259-432, D262-411,
D265-453, D271-366, D280-317, D278-470, D286-185, D284-257,
D288-188, D288-186, D288-214.
Manufacturer: Lederle Laboratories Division, American Cyanamid Company,
Pearl River, New York.
Recalled by: Manufacturer, by letter on or about April 24, 1991.
Firm-initiated recall ongoing.
Distribution: California, Illinois, Philadelphia, Texas.
Quantity: (a) 3,424 bottles; (b) 8,691 bottles were distributed.
Reason: Product does not meet loss on drying specifications.
----
Product: Hydrox Solution of Hydrogen Peroixde 3% USP, 10 Volume,
in 1 pint brown plastic bottles, an OTC topical liquid
first aid antiseptic. Recall #D-493-1.
Code: Lot #5491 EXP 4/94.
Manufacturer: Hydrox Chemical Company, Elk Grove Village, Illinois.
Recalled by: Manufacturer, by telephone July 1, 1991 followed by
letter July 2, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 650 cases (12 bottles per case) were distributed; firm
estimates 25 percent remains on the market.
Reason: Superpotent.
----
Product: (a) Red Blood Cells; (b) Fresh Frozen Plasma;
(c) Platelets; (d) Cryoprecipitated AHF; (e) Platelets,
Pheresis; (f) Red Blood Cells, Expired; (g) Platelets,
Expired; (h) Recovered Plasma. Recall #B-329/336-1.
Code: All blood components drawn from December 5, 1990 through
March 29, 1991, except those units listed in the Class II
recall.
32FS00929 through 32FS00969, 32FS01412 through 32FS01629,
32FS01965 through 32FS02004, 32FS06016 through 32FS06044,
32FS07346 through 32FS07385, 32M82595, 32M82643 through
32M82682, 32M83086 through 32M83135, 32M83136 through
-8-
32M83166, 32M83180,32M83192, 32M83194, 32M83195, 32M83203,
32M83449 through 32M83491, 32M83589 through 32M83609,
32M83844 through 32M83884, 32M84339 through 32M84371,
32M84542 through 32M84562, 32M84694 through 32M84711,
32M85172 through 32M85203, 32M85322 through 32M85354,
32M85651 through 32M85679, 32M85850 through 32M85869,
32P32403 through 32P32501, 32P39746 through 32P40000.
Manufacturer: American Red Cross Blood Services, Green Bay, Wisconsin.
Recalled by: Manufacturer, by telephone April 15, 1991 and by
letter April 25, 1991. Firm-initiated recall ongoing.
Distribution: Wisconsin, Illinois, Iowa, Michigan, New Jersey, Texas,
Arkansas, Pennsylvania, South Carolina, Massachusetts,
California, Switzerland.
Quantity: Blood products from approximately 750 donors.
Reason: Blood products, tested for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1) in a manner not
consistent with the manufacturer's test kit instructions,
were distributed.
----
DEVICES AND RADIOLOGICAL PRODUCTS
NONE
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Benamine Solution (Flunixin Meglumine), in 100 ml
vials. Recall #V-074-1.
Code: Lot #1-CNX-103 EXP 3/93.
Manufacaturer: Schering Plough Products, Inc., Manati, Puerto Rico.
Recalled by: Manufacturer, by letter June 11, 1991. Firm-initiated
recall ongoing.
Distribution: Nebraska.
Quantity: 1,019 vials were distributed; firm estimates 800 vials
remain on the market.
Reason: Particulate matter, identified as copper sulfide,
found in vials.
----
Class III -
NONE
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Seizure Actions Filed:
Product: Mayonnaise (91-529-151).
Charge: Misbranded - Product labeled as mayonnaise and does not
conform to the definition and standard of identity;
Adulterated - A valuable consituent has been in whole
or in part omitted.
Firm: Mardale, Inc., Waukegan, Illinois.
Filed: June 19, 1991 - U.S. District Court for the Western
District of Wisconsin; Civil #91-C-547-S, FDC #66169.