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
01/22/1991
FDA Enforcement for the week of January 23, 1991
FDA ENFORCEMENT REPORT
FOR JANUARY 23, 1991
January 23, 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.
NONE
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: (a) Keebler Honey Grahams, 16 ounces, Item #02915;
(b) Keebler Mini Middles Shortbread Cookies, 11 ounces,
Item #14225;
(c) Keebler Unsalted Tops Zesta Crackers, 16 ounces,
Item #40410;
(d) Kraft Individual 2 Count Cottage Crackers.
Recall #F-701/704-0.
Code: Products were produced on Julian date 211 (July 30,
1990). Lot number on the Kraft case carton is 211GYOE.
Manufacturer: Keebler Company, Denver, Colorado.
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Recalled by: Keebler Company, Elmhurst, Illinois, by telephone August
9, 1990. Firm-initiated recall ongoing.
Distribution: Nebraska, Missouri.
Quantity: 55 cases of the Cottage Crackers, 11 cases of Honey
Grahams, 40 cases of Mini Middles Shortbread Cookies and
5 cases of Zesta Unsalted Tops Saltines.
Reason: Products may contain wire fragments.
----
Product: ICAPS Plus, a vitamin and mineral supplement:
(a) 120 Softgel Cap; (b) 12 Softgel cap bottles.
Recall #F-053/054-1.
Code: Lot numbers: NP48433, NP48434, NP48435, NP48436.
Manufacturer: Pharmacaps, Inc., Elizabeth, New Jersey.
Recalled by: La Haye Laboratories, Medina, Washington, by mailgram
April 3, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 5,000 bottles were distributed.
Reason: Capsules contain zinc polynicotinate instead of zinc
picolinate.
----
Product: Sholar's brand (a) Self Rising Corn Meal Mix, in 5 pound
and 24 ounce bags;
(b) Medium Ground Corn Meal, in 5 pound and 2 pound bags;
(c) Fine Ground Corn Meal, in 5 pound and 2 pound bags;
(d) Riverbank Buttermilk Hush Puppy Mix, in 16 ounce
bags;
(e) Shake & Fry, in 12 ounce bags;
(f) Sike's brand Corn Meal Medium Grind, in 2 pound bags.
Recall #F-100/105-1.
Code: All product manufactured prior to November 13, 1990.
Manufacturer: C&C Corn Products, Inc., Pelham, Georgia.
Recalled by: Manufacturer, by visit on or about November 15, 1990.
Firm-initiated recall complete.
Distribution: Georgia.
Quantity: Unknown.
Reason: Product is contaminated with aflatoxin.
----
Product: Assorted frozen popsicles: (a) Cherry flavored;
(b) Orange flavored; (c) Grape flavored.
Recall #F-111/113-1.
Code: Lot #2180.
Manufacturer: McArthur Dairy, Fort Lauderdale, Florida.
Recalled by: Manufacturer, by letter September 26, 1990. Firm-
initiated recall ongoing.
Distribution: Florida.
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Quantity: 5,928 units were distributed.
Reason: Product contains calcium chloride.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Canned mushrooms: (a) Green Giant Pieces and Stems,
8 ounces; (b) B in B Broiled in Butter Pieces and
Stems, 3 ounces. Recall #F-098/099-1.
Code: All products with two line codes having the following
bottom lines: COR23 through COR 31 and DOR01 through DOR14.
Manufacturer: Pillsbury Company, Minneapolis, Minnesota/PT Dieng Djaya
Indonesia.
Recalled by: Manufacturer, by letter dated October 12, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 5,000 cases remain on market.
Reason: Product exceeded defect action level for mites.
----
Product: Hershey's Genuine Chocolate Flavored Drink,
in 8 fluid ounce brick packs. Recall #F-106-1.
Code: On back panel: 79LB, 79MB, 79NB, 80DB, 80EB, 80FB, 80KB,
80LB, 80MB, 81DB.
Manufacturer: Gossner Foods Inc., Logan, Utah.
Recalled by: Hershey Chocolate USA, Division of Hershey Foods Corporation,
Hershey, Pennsylvania, by visit October 26, 1990.
Firm-initiated recall complete.
Distribution: Eastern United States.
Quantity: 34,965 cases were distributed.
Reason: Product contained in swollen, leaking containers.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Timentin, an Rx antibacterial, in 3.1 gm sterile powdered
form for intravenous administration, a combination of
sterile Ticarcillin Disodium and Clavulanate Potassium used
for treatment of infections. Recall #D-140-1.
-3-
Code: Lot numbers: NK4714 EXP 12/91, NK4719, NK4732 EXP 12/91,
NK4737 12/91.
Manufacturer: Smithkline Beecham Pharmaceuticals, Piscataway, New
Jersey.
Recalled by: Smithkline Beecham Pharmaceuticals, Philadelphia,
Pennsylvania, by letter October 31, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 14,002 piggyback bottles; 6,910 50 cc vials; and 10,800
Add-Vantage 20 cc vials were distributed.
Reason: Lack of assurance of sterility.
----
Product: Compressed Medical Oxygen, in steel cylinder sizes
B, D, E, F, M, H, HH, aluminum tanks sizes D and E,
an Rx product. Recall #D-144-1.
Code: All lots with fill dates of 6/1/90 to 12/05/90.
Manufacturer: Aero All-Gas, Hartford, Connecticut.
Recalled by: Manufacturer, by telephone October 10, 1990 and by
letter December 21, 1990. Firm-initiated recall ongoing.
Distribution: Connecticut, Massachusetts.
Quantity: Firm estimates 2-5 thousand cylinders were distributed.
Reason: Oil contamination of cylinders.
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Product: Cefuroxime Sodium, Glaxo 1.5g vials, packaged 10 vials/
carton, an Rx semisynthetic, broad-spectrum cephalosporin
antibiotic for parenteral administration. Recall #D-151-1.
Code: Lot #2323 EXP 2/92.
Manufacturer: Glaxo Spa, Verona, Italy.
Recalled by: Glaxo, Inc., Zebulon, North Carolina, by telephone
December 21, 1990 followed by letter. Firm-initiated
field correction ongoing.
Distribution: Nationwide.
Quantity: 2,469 units were distributed (1 unit equals 10 vials).
Reason: Some correctly labeled 1.5 g vials were packaged in
unit cartons labeled 750 mg.
----
Product: Carisoprodol Tablets, USP, 350 mg., an Rx skeletal muscle
relaxant, packaged in bottles of 100, 500, and 1,000
tablets, under the Bolar, Goldline, Bioline and Major
Pharmaceutical labels. Recall #D-152-1.
Code: Lot #019856 EXP 3/92.
Manufacturer: Bolar Pharmaceutical Co., Inc., Copiague, New York.
Recalled by: Manufacturer, by letter October 12, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
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Quantity: 17,336 bottles of 100, 2,745 bottles of 500 and 813
bottles of 1,000 were distributed; firm estimates 100,000
tablets remain on market.
Reason: Product does not meet dissolution specifications and is
subpotent.
-----
Product: (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Recovered Plasma. Recall #B-080/083-1.
Code: Unit #14F26941.
Manufacturer: American Red Cross, Yakima, Washington.
Recalled by: Manufacturer, by telephone January 8 and 10, 1990
followed by letters of November 14 and 15, 1990.
Firm-initiated recall complete.
Distribution: Washington state.
Quantity: 1 unit of each component were distributed.
Reason: Blood components collected from a donor who had been
tattooed two months prior to donation, were distributed.
----
Product: Platelets. Recall #B-086-1.
Code: Unit #38FN01018.
Manufacturer: American Red Cross Blood Services, Fort Wayne, Indiana.
Recalled by: Manufacturer, by telephone May 11, 1990 followed by
letter May 17, 1990. Firm-initiated recall complete.
Distribution: Indiana.
Quantity: 1 unit.
Reason: Platelets were collected from donors who reported a positive
test for infectious mononucleosis the day after donation,
was distributed for transfusion.
----
CORRECTION: Erythromycin Ophthalmic Ointment (5 mg/g), in 1 gram
tubes under the Pharmafair, H.L. Moore, Akorn, Lowgen,
Goldline and Best labels, Recall #D-128-1 which appeared
in the December 26, 1990 Enforcement Report should read:
Code: Lot numbers 8268 EXP 9/91, 8743 EXP 10/91,
8685 EXP 8/91 (relates to 1 gram size);
Lot #8685 EXP 8/93 (relates to 3.5 gram size).
----
Class III -
Product: An OTC product, GROWTH, in 2 ounce bottles, a combination of
glandular extracts purchased by individuals desiring
to increase muscle mass and strength. Recall #D-141-1.
Code: All lots.
Manufacturer: Botanical Laboratories, Inc., Bellingham, Washington.
-5-
Recalled by: Basic Organics, Inc., Whithall, Ohio, by telephone on
or about December 6, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 60 bottles were distributed.
Reason: Product marketed without new drug approval.
----
Product: Aspirin Tablets, 5 grains, in bottles of 100
and 300 tablets, an OTC oral tablet for pain relief.
Recall D-142-1.
Code: Lot numbers: 9GZX, 9GZW, 9HFO/B.
Manufacturer: Walgreen Laboratories, Inc., also known as X-Cel
Laboratories, Kalamazoo, Michigan.
Recalled by: Walgreen Company, Deerfield, Illinois, by electronic
messages October 12, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 157,148 bottles of 100 and 12,370 bottles of 300 tablets
were distributed.
Reason: Product does not meet dissolution specifications.
----
Product: Tylenol Extra Strength 24 Caplets, 500 mg, an OTC
analgesic. Recall #D-143-1.
Code: Lot numbers FAA 742 and FBA 802 EXP 12/94.
Manufacturer: McNeil Consumer Products, Fort Washington, Pennsylvania.
General Wholesalers, Inc., Trujillo Alto, Puerto Rico
(wholesaler).
Recalled by: Latin American Distributors, Inc., Perth Amboy, New Jersey,
by letter November 9, 1990. Firm-initiated recall ongoing.
Distribution: New Jersey, New York, Pennsylvania.
Quantity: 120 dozen bottles were distributed.
Reason: Product was distributed in the USA with label in Spanish
language only.
----
Product: Nitrous Oxide USP in E & H size cylinders and 10-20 pound
size cylinders, an Rx product. Recall #D-145-1.
Code: Lot #09249004.
Manufacturer: Lincoln Welding Supply Company, Lincoln, Nebraska.
Recalled by: Manufacturer, by telephone December 6-7, 1990.
Firm-initiated recall ongoing.
Distribution: South Dakota, Iowa, Nebraska, Missouri.
Quantity: 108 "E" cylinders; 13 "H" cylinders, 4 twenty pound
cylinders; 2 ten pound cylinders.
Reason: Current good manufacturing practice deviations.
----
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Product: (a) 1% Xylocaine (Lidocaine HCl) Injection 10 mg/ml,
with Epinephrine, 1:200,000 in 5 ml single dose vials;
(b) 1.5% Xylocaine (Lidocaine HCl) Injection, 15 mg/ml,
with Epinephrine, 1:200,000 in 5 ml single dose vials;
(c) 2% Xylocaine (Lidocaine HCl) Injection, 20 mg/ml,
with Epinephrine, 1:200,000 in 5 ml single dose vials.
Recall #D-146/148-1.
Code: Lot numbers: (a) 901050 EXP 1/91, 908165 EXP 8/91;
(b) 903066 EXP 3/91, 906133 EXP 6/91;
(c) 901063 EXP 1/91, 908112 EXP 8/91, 910151 EXP 10/91.
Manufacturer: Astra Pharmaceutical Products, Inc., Westboro, Massachusetts.
Recalled by: Manufacturer, by letter September 10, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 28,500 vials; (b) 11,090 vials; (c) 24,270 vials
were distributed.
Reason: Potency of Epinephrine ingredient not assured through
expiration date.
----
Product: Conjugated Estrogen Tablets USP 1.25 strength tablets,
in bottles of 100 and 1000, an Rx product used for treating
estrogen deficiencies in post-menopausal women, under the
Aligen, Best, Bioline, Duramed, Geneva, Goldline, Major,
Moore, Parmed, Purepac, Qualitest, Rugby, Schein and URL
labels. Recall #D-149-1.
Code: All lots of 1990 production: 91948, 91949, 91950, 91951,
91952, 91982 through 91994, 92013, 92014, 92015,
92017, 92018, 92019, 92157, 92159, 92160, 92161, 92163,
92164.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by letter December 12, 1990. Firm initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 19,782 bottles of 1,000 and 78,681 bottles of 100 tablets
were distributed.
Reason: Some lots failed USP content uniformity requirements;
others lack assurance of meeting uniformity requirements.
----
Product: Film Coated Aspirin, USP 325 mg tablets, in bottles of 100,
an OTC product. Recall #D-150-1.
Code: Lot numbers: 006224 EXP 5/93, 008011 EXP 2/93,
008023 EXP 4/93.
Manufacturer: Granutec, Inc., Wilson North Carolina.
-7-
Recalled by: Manufacturer, by telephone December 19, 1990 followed by
letter dated December 20, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide.
Quantity: 31,392 bottles were distributed.
Reason: Bottle label bears inaccurate pregnancy/nursing statement
as required by regulation 201.63.
----
Product: Enteric-Coated Aspirin Tablets, USP, 325 mg, an OTC product
used for temporary relief of minor pains due to arthritis
and Rheumatism, under the Advance Pharmaceutical
labels in bottles of 100 and 1,000 and under the Logen
Pharmaceuticals label in bottles of 100 and 1,000.
Recall #D-153-1.
Code: Lot #90D001 EXP 4/92.
Manufacturer: Advance Pharmaceutical, Inc., Ronkonkoma, New York.
Recalled by: Manufacturer, by letter November 1, 1990. Firm-initiated
recall ongoing.
Distribution: New York, New Jersey.
Quantity: 1,872 units of 100 and 334 units of 1,000 tablets were
distributed.
Reason: Product does not meet USP specifications for drug release.
----
Product: Actedril Nasal Decongestant Antihistamine 1000 Tablets,
each tablet containing Pseudoephedrine Hydrochloride 50 mg
and Triprolidine Hydrochloride 2.5 mg, an OTC product
indicated for temporary relief of nasal congestion due to
common cold, hay fever or other respiratory allergies under
the Advance Pharmaceutical label in bottles of 24, 100, and
1,000 tablets and under the Logen Pharmaceuticals label
in bottles of 100 and 1,000 tablets. Recall #D-154-1.
Code: Lot #89H003 EXP 8/91.
Manufacturer: Advance Pharmaceutical, Inc., Ronkonkoma, New York.
Recalled by: Manufacturer, by letter October 23, 1990. Firm-initiated
recall ongoing.
Distribution: New York, Illinois, New Jersey.
Quantity: 288 units of 24; 1,776 units of 100; 531 units of 1,000
tablets were distributed.
Reason: Product does not meet content uniformity specifications for
triprolidine ingredient.
----
Product: Red Blood Cells, Leukocytes Removed. Recall #B-077-1.
Code: Unit #3213388 (original unit #3471491).
Manufacturer: J.K. & Susie L. Wadley Research Institute and Blood
Bank, Dallas, Texas.
Recalled by: Manufacturer, by telephone August 15, 1989. Firm-
initiated recall complete.
-8-
Distribution: Texas.
Quantity: 1 unit.
Reason: Blood component collected from a donor who had taken
prophylactic anti-malarial medications two years prior
to donation and received a measles vaccination three
to four weeks prior to donation was distributed.
----
Product: (a) Red Blood Cells; (b) Platelets. Recall #B-087/088-1.
Code: Unit numbers: (a) 38F62753, 38J22267, 38T28369;
(b) 38F62753.
Manufacturer: American Red Cross Blood Services, Fort Wayne, Indiana.
Recalled by: Manufacturer by letter February 6, 1990 and by letter
July 30, 1990. Firm-initiated recall complete.
Distribution: Indiana.
Quantity: (a) 3 units; (b) 1 unit.
Reason: Blood products collected from donors who 1) reported
a positive test for infectious mononucleosis the day
after donation, 2) took anti-malarial prophylaxis one year
prior to donation, or 3) travelled in an area endemic for
malaria three months prior to donation, were distributed.
----
MEDICAL DEVICES AND RADIOLOGY
NONE
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Chlortetracycline (CTC) Medicated Blocks Lab Lix 20%
Anaplas-Aureo. Recall #V-054-1.
Code: All codes.
Manufacturer: Manna Pro Corporation, Kansas City, Kansas.
Recalled by: Manufacturer, by letter September 24, 1990. Firm-initiated
recall ongoing.
Distribution: Missouri, Kansas, Oklahoma, Arkansas, Mississippi.
Quantity: 7,513 blocks were distributed; firm estimates 220 blocks
remain on the market.
Reason: Product is an unapproved new animal drug.
----
Class III -
NONE
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