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
12/18/1991
Recalls and Field Corrections: December 18, 1991
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: Wisconsin Fancy Jac Semi-Soft Cheese, in individually
weighed packages of approximately 1 and 5 pounds each.
Recall #F-073-2.
Code: None.
Manufacturer: Cloverleaf Cheese, Inc., Stanley, Wisconsin.
Recalled by: Burnett Dairy Cooperative, Grantsburg, Wisconsin, by
telephone October 28 and 29, 1991, and November 4, 1991.
Firm-initiated recall ongoing.
Distribution: Minnesota, Wisconsin, Iowa.
Quantity: Approximately 12,500 pounds were distributed; firm
estimates that about 4,000 pounds remain on the market.
Reason: Product is contaminated with Listeria monocytogenes.
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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: Fudge ice cream, in one-half gallon round cardboard
containers:
(a) Kemps Old Fashioned Brownie Fudge Swirl Ice Cream,
also in 3 gallon containers, distributed by Marigold
Foods;
(b) Skondra's Brownie Nut Fudge Ice Cream, distributed by
Sunrise Dairy;
(c) Byerly's Brownie Nut Fudge Ice Cream, distributed by
Byerly's Distributors. Recall F-075/077-2.
Code: All lots.
Manufacturer: Marigold Foods, Inc., Rochester, Minnesota.
Recalled by: Marigold Foods, Inc., Minneapolis, Minnesota, by
inter-office correspondence November 18, 1991.
Firm-initiated recall ongoing.
Distribution: (a & b) The Midwest; (c) Minnesota.
Quantity: (a) 38,253 one-half gallons and 1,920 three-gallon
containers; (b) 22,437 one-gallon containers;
(c) None were distributed.
Reason: Product contains undeclared walnuts.
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Product: Various dairy products:
(a) Chocolate Vitamin A & D 2% Lowfat Milk, 3 gallon
dispensers, half pint cartons, 10 fluid ounce cartons
pint cartons, quart cartons, half and gallon cartons
under Best-Ever brand; half pint cartons, pint cartons,
quart cartons and half gallon cartons under Thompson's and
Wayne Dairy brand;
(b) Chocolate Vitamin A & D 1% Low Fat Milk, in
half pint cartons, under Best-Ever, Thompson's, and
Riggins brand;
(c) Pasteurized Chocolate Milk, plastic gallon containers,
Best-Ever brand;
(d) Artificially Flavored Fruit Punch, plastic gallon
containers, 16 and 32 fluid ounce cartons, Best-Ever brand;
(e) Artificially Flavored Orange Drink, plastic
gallon and in 10 fluid ounce cartons, Best-Ever brand;
(f) Double Pop Ice Cream Mix, 4,000 pounds bulk.
Recall #F-078/083-2.
Code: Pull dates: (a) Nov. 1/Nov. 2; (b) Nov. 1/Nov. 2;
(c) Nov. 7; (d) Jan. 17 (gallons), Dec. 1 (pints and
quarts; (e) Jan. 17 (gallons), Dec. 1 (10 ounces);
(f) None.
Manufacturer: Eastside Jersey Dairy Company, Inc., Anderson, Indiana.
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Recalled by: Manufacturer, by telephone October 18, 1991, and by
letter October 19, 1991. Firm-initiated recall complete.
Distribution: Indiana.
Quantity: Firm estimates none remains on the market.
Reason: Product contained undeclared sulfites.
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Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Seven Seas Free Fat Free and Cholesterol Free Ranch
Nonfat Salad Dressing, in 16 fluid ounce glass bottles.
Recall #F-074-2.
Code: Best when purchased before: MAR2592X7.
Manufacturer: Kraft General Foods, Decatur, Georgia.
Recalled by: Kraft General Foods, Inc., Glenview, Illinois, by
"Urgent Product Withdrawal" memorandums dated November
6, 1991. Firm-initiated recall ongoing.
Distribution: New Jersey, Kansas, Louisiana, Florida, Arizona,
Montana.
Quantity: 1,895 cases (12 bottles per case) were distributed;
firm estimates that 75 percent of the product remains
on the market.
Reason: Product is contaminated with lactobacillus.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: (a) Fluocinolone Acetonide Topical Cream, 0.01%;
(b) Fluocinolone Acetonide Topical Cream, 0.25%.
Recall #D-106/107-2.
Code: Lot numbers: (a) 8289; (b) 9518.
Manufacturer: Pharmafair, Inc., Hauppague, New York.
Recalled by: Manufacturer, by letter September 23, 1991. Firm-initiated
recall ongoing.
Distribution: Connecticut, Washington, North Carolina, California,
Texas.
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Quantity: (a) 677 units; (b) 849 units were distributed.
Reason: Subpotency.
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Product: (a) Pilocarpine HCl Solution 4%, sterile Rx ophthalmic
used to manage intraocular pressure in glaucoma, in
15 ml bottles;
(b) Sodium Chloride Solution 5%, OTC for use in
temporary relief of corneal edema, in 15 ml and 30 ml
bottles;
(c) Polyvinyl Alcohol Solution 1.4%, OTC for the temporary
relief of burning and irritation due to dryness of the
eye, in 15 ml bottles;
(d) Hydroxyproplymethyl Cellulose Solution 2.5%, OTC
for professional use in Gonicoscopic examination, in
15 ml bottles;
(e) Neomycin and Polymixin B Sulfates and Hydrocortisone
Otic Solution USP, a Rx antibacterial and anti-
inflammatory solution for otic use, in 10 ml bottles;
(f) Neomycin and Polymixin B Sulfates and Hydrocortisone
Otic Suspension, a Rx sterile antimicrobial/anti-inflammatory
suspension formulated for otic use, in 10 ml bottles.
Recall #D-109/114-2.
Code: Lot numbers: (a) 0320 EXP 5/94, 0352 EXP 5/94;
(b) 0315 EXP 5/95, 0360 EXP 5/95, 0387 EXP 6/95;
(c) 0325 EXP 11/93; (d) 0363 EXP 6/93; (e) 0381 EXP 6/94,
0394 EXP 6/94; (f) 0201 EXP 8/93.
Manufacturer: Pharmafair, Inc., Hauppauge, New York.
Recalled by: Manufacturer, by letter October 30, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 60,000 units; (b) 74,000 units; (c) 30,000 units;
(d) 15,000 units; (e) 86,000 units; (f) 42,000 units
were distributed.
Reason: Lack of assurance of sterility.
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Class III -
Product: ORA5, a topical bactericidal agent for oral mucosa, in
1 ounce brown glass bottles. Recall #D-103-2.
Code: Lot 63.
Manufacturer: Summer Laboratories, Fort Washington, Pennsylvania.
Recalled by: McHenry Laboratories, Inc., Edna, Texas, by letter
October 15, 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
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Quantity: 2,620 bottles were distributed; firm estimates 524
bottles remain on the market.
Reason: Subpotent in iodine content.
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Product: Pipracil, sterile piperacillin sodium, in 40 gram vials
for IM and IV use as a broad spectrum antibiotic.
Recall #D-104-2.
Code: Lot numbers: 313-712, 315-706, 315-707, 315-708,
315-709, 315-710, 315-711.
Manufacturer: Lederle Parenterals Inc., Carolina, Puerto Rico.
Recalled by: Lederle Laboratories, Pearl River, New York, by
telephone October 4, 1991 followed by letter October 25,
1991. Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 20,844 vials were distributed.
Reason: The outer box incorrectly declares 180 ml of sterile water
to be added instead of the correct 172 ml. The container
label and package insert are correct.
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Product: Hydrocortisone 0.5% Cream, in 30 gram, 15 gram, and in
1 pound sizes. Recall #D-105-2.
Code: Lot numbers (30 gm) 5515, 5763, 5803, 7185, 7219, 7233,
7267, 7547, 8296, 8363, 8434, 8678, 8679, 8756, 9210, 9211,
9322; (15 gram) 5763; (l lb) 7267.
Manufacturer: Pharmafair, Inc., Hauppague, New York.
Recalled by: Manufacturer, by letter dated September 23, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 197,500 units of 30 gram size, 2,570 units of 15 gram
size and 120 units of the 1 pound size were distributed.
Reason: Lack of stability data to support expiration date.
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Product: Bausch & Lomb brand Acetic Acid 2% and Aluminum Acetate
Otic Solution, USP sterile, a Rx drug for the treatment
of superficial infections of the external auditory canal.
Recall #D-108-2.
Code: Lot numbers: 0106 7/93, 0203 9/93, 7798 11/91, 7803 11/91,
8144 3/92, 8204 4/92, 8205 4/92, 8266 4/92, 8273 5/92,
8348 5/92, 9852 2/93, 9993 5/93.
Manufacturer: Pharmafair, Inc., Hauppauge, New York.
Recalled by: Manufacturer, by letter October 30, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 150,000 units were distributed.
Reason: Aluminum acetate ingredient is subpotent.
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Product: Calamine Lotion, in 4 ounce bottles, an OTC product
available in lotion form, applied topically to dry the
oozing and weeping of poison ivy, oak, and sumac, under
Barre-National, Major, Quality, Valumed, and Revco labels.
Recall #D-115-2.
Code: Lot #03680 EXP 9/94.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter October 28, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 38,098 bottles were distributed; firm estimates 3,334
bottles remain on the market.
Reason: Zinc Oxide ingredient outside of potency specification.
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Product: Lactulose Syrup USP, a Rx drug sold under the
names of Constulose in 8 and 32 ounce bottles and Enulose
in 16 and 64 ounce bottles. Recall #D-116-2.
Code: Lot #13407 EXP 5/93, 11/92.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter November 6, 1991. Firm-inititaed
recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: 31,278 bottles were distributed; firm estimates 11,736
bottles remain on the market.
Reason: Product contained particulate matter.
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Product: Barre Drug brand Gentian Violet, in 30 ml units, an OTC
product. Recall #D-117-2.
Code: Lot #91583 EXP 5/93.
Manufacturer: Cumberland-Swan, Inc., Smyrna, Tennessee.
Recalled by: Barre-National, Inc., Baltimore, Maryland, by letter
October 25, 1991. Firm-initiated recall ongoing.
Distribuiton: Nationwide.
Quantity: 10,728 units were distributed; firm estimates none
remains on the market.
Reason: Superpotency.
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DEVICES AND RADIOLOGICAL PRODUCTS
NONE
VETERINARY PRODUCTS
NONE
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Seizure Actions Filed:
Product: Rice Bran, Chick Peas, Uridall Split (Peas) (91-503-631/633).
Charge: Adulterated - The articles consist in part of a filthy
substance (insects and insect filth) and have been held
under insanitary conditions whereby they may have become
contaminated.
Firm: Berkshire Foods, Chicago, Illinois.
Filed: December 5, 1991 - U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #91C7815,
FDC #66333.
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Product: Breaded Shrimp (91-543-709).
Charge: Misbranded - Product is represented as a food for
which a definition and standard of identity has been
prescribed by regulation and it does not conform to such
definition and standard since the product contains less
than 50 percent shrimp because excess breading material
has been substituted in part for shrimp, and the label
does not bear the common or usual names of optional
ingredients present.
Firm: Rich-Seapak Corporation, St. Simons Island, Georgia.
Filed: October 31, 1991 - U.S. District Court for the Western
District of New York; Civil #91-0536-E, FDC #66243.
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Product: Neuromuscular Stimulators with Electrode Catheters (used
to treat neurogenic bladder disease, particularly in
infants and small children) (91-660-859/60).
Charge: The products are Class III devices and they fail to
have an approved application for premarket approval and
they are not exempt from this requirement; also, the
foreign manufacturer of the devices, Horst Hamedinger,
is not registered, has not listed the devices and no
notice or other information concerning the devices has
been provided as required.
Firm: William E. Kaplan, M.D., pediatric urologist, doing
business as Children's Urology, Ltd., Chicago, Illinois.
Filed: December 5, 1991 - U.S. District Court for the
Northern District of Illinois, Eastern Division;
Civil #91C7824, FDC #66279.
Seized: December 10, 1991; seizure of nine units, 104 catheters,
and 2-1/2 boxes of brochures valued at about $13,000
was accomplished.
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Product: Sporicidin Cold Sterilizing Solution, Sporocidin-HD,
Sporicidin brand Disinfectant Solution, Sporicidin
brand Disinfectant Spray and Sporicidin Disinfectant
towelettes (used to sterilize or disinfect certain
medical instruments, equipment and fiberoptics used in
endoscopic surgery, anesthesiology and respiratory
therapy) (91-585-880).
Charge: The products failed effectiveness tests, lacked FDA
clearance for labeling claims and were a danger to
health.
Firm: Sporicidin Company, Rockville, Maryland (firm's
headquarters); Multi-Modal Freight Systems (a distribution
warehouse), Baltimore, Maryland; and Chem-Mix, Inc.
a contract manufacturing facility), Jonesborough, Tennessee.
Filed: December 13, 1991 - U.S. District Court for the District
of Maryland, Civil #MJG 91-3542, FDC #66265; U.S.
District Court for the Eastern District of Tennessee,
Northern Division, Civil #2-91-416, FDC #66263.
Seized: December 13, 1991. Joint venture involving FDA with the
Environmental Protection Agency, the Federal Trade
Commission and the U.S. Attorney's offices in Baltimore,
Maryland, and Nashville, Tennessee.
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