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
05/13/1992
INFORMATION FOR READERS OF THE FDA ENFORCEMENT REPORT: May
13, 1992
92-20
SUBJECT Changes in format for the FDA Enforcement Report.
To conserve space, and improve the ease of use, it has become
necessary to adjust the arrangement of headings and text.
Editions will no longer include titles for categories not used
along with the word "none." Instead, categories not needed for
the week's listings will be omitted. Other changes include the
addition of two new categories, Indictments and Informations,
and the placement of Class I, II, and III descriptions under
the Recall definition on the front cover page.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
PRODUCT Chopped Clams, in 6.5 ounce cans. Recall #F-286-2.
CODE DEC 94 2356Q.
MANUFACTURER American Original Foods, Cannon, Delaware.
RECALLED BY Borden, Inc., Columbus, Ohio, by letter March 3, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 29,760 cans were distributed.
REASON Potential for Clostridium Botulinum Toxin (underprocessed).
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Hagen French Vanilla Ice Cream, in one quart containers.
Recall #F-276-2.
CODE 21892.
MANUFACTURER Hagen Ice Cream Company, Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by letter March 13 and 25, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Pennsylvania, West Virginia, Ohio, Maryland.
QUANTITY 371 cases (4 quarts per case) were distributed; firm estimates
none remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
PRODUCT Various styles of shark meat:
(a) Blacktip Shark, whole dressed in waxed carton, various
sizes;
(b) Mako Shark, whole dressed in waxed carton;
(c) Mako Shark, whole dressed, no labeling attached;
(d) Thresher Shark, whole dressed, no labeling attached.
Recall #F-278/280-2 and F-287-2.
CODE None.
MANUFACTURER L.D. Armory & Company, Inc. (dealer), Hampton, Virginia.
RECALLED BY Manufacturer, (a) by letter February 26, 1992; (b) by telephone
March 10, 1992; (c & d) by telephone April 2-3, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION (a) Illinois, Michigan, Ohio, Florida; (b) New Jersey,
Connecticut, Virginia, Florida; (c & d) Virginia, New Jersey,
Illinois.
QUANTITY (a) 2,550 pounds; (b) 631 pounds; (c) 1,167 pounds; (d) 680
pounds were distributed.
REASON Product is contaminated with excessive levels of methyl mercury.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Frozen Peeled Shrimp, in 5 pound boxes. Recall #F-275-2.
CODE Product #3978GC - Fresh Frozen Shrimp, Manufacturer Code 051:2.
MANUFACTURER Gulf City Seafood, Inc., Pascagoula, Mississippi.
RECALLED BY Manufacturer, by telephone and letter on or about February 23,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Virginia.
QUANTITY 69.9 cases were distributed.
REASON Product is short of the declared weight.
PRODUCT Imitation Mini Round Breaded Shrimp, in 3 pound plastic bags.
Recall #F-277-2.
CODE Product #5048 JBB, Lot numbers: 7139, 7257, 7284
Product #5048 SFB, Lot numbers: 7285, 7258, 7268.
MANUFACTURER Gulf City Seafood, Inc., Pascagoula, Mississippi.
RECALLED BY Manufacturer, by telephone and letter on or about February 23,
1992. Firm-initiated recall ongoing.
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DISTRIBUTION Utah, Mississippi, Michigan, Colorado.
QUANTITY 422 cases were distributed
REASON Product fails to declare the presence of Sodium
Tripolyphosphate (STP).
PRODUCT Puritan's Pride Wild Cherry Flavor Liquid Protein, in 16 ounce
and 32 ounce plastic bottles. Recall #F-281-2.
CODE Lot numbers: 1162, 1260, and 1261 were manufactured under the
Puritan's Pride label product code 833 for 16 ounce and 835 for
the 32 fluid ounce bottles.
MANUFACTURER Nature's Bounty, Inc., Bohemia, New York.
RECALLED BY Manufacturer, by letter March 23, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,491 bottles were distributed.
REASON Product is contaminated with Lactobacillus and Diplococci.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
PRODUCT Puritan's Pride brand Natural Panthenol Shampoo and Hair
Conditioner, in 8 fluid ounce plastic bottles. Recall #F-282-2.
CODE Lot numbers 0905, product code 2530, 1277, product code 2530.
MANUFACTURER Nature's Bounty, Inc., Bohemia, New York.
RECALLED BY Manufacturer, by letter March 13, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,384 bottles were distributed.
REASON Product is contaminated with Pseudomonas Aeruginosa.
PRODUCT Puritan's Pride brand Natural Panthenol Hair Thickener and
Conditioner, in 8 fluid ounce plastic bottles. Recall #F-283-2.
CODE Lot ##0844, product code 2300.
MANUFACTURER Nature's Bounty, Inc., Bohemia, New York.
RECALLED BY Manufacturer, by letter March 13, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,384 bottles were distributed.
REASON Product is contaminated with Pseudomonas Aeruginosa.
PRODUCT Puritan's Pride Natural Jojoba Shampoo and Conditioner, in 8
fluid ounce plastic bottles. Recall #F-284-2.
CODE Lot numbers: 0839, 1276, 0519, product code 2830.
MANUFACTURER Nature's Bounty, Inc., Bohemia, New York.
RECALLED BY Manufacturer, by letter March 13, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12,640 bottles were distributed.
REASON Product is contaminated with Pseudomonas Aeruginosa.
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PRODUCT Vitamin E Hand and Face Lotion, in 4 fluid ounce plastic
bottles, under the Puritan's Pride Nature's Bounty and Hudson
labels. Recall #F-285-2.
CODE Lot #0994 (Hudson, Puritan's Pride and Nature's Bounty label);
Lot #29431 (Puritan's Pride label). Product code 3210.
MANUFACTURER Nature's Bounty, Inc., Bohemia, New York.
RECALLED BY Manufacturer, by letters of March 13 and 20, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10,557 bottles were distributed.
REASON Product is contaminated with Pseudomonas Aeruginosa.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Perphenazine/Amitriptyline HCl Tablets (a) 2/10 mg; (b) 2/25
mg; (c) 4/50 mg strengths, in bottles of 100, 250 and 500, a Rx
antidepressant, distributed under the following labels: Major,
Harber, Rugby, PAR, Quad. Recall #D-331/333-2.
CODE All lots still within their expiration dates.
MANUFACTURER Par Pharmaceuticals, Inc., Spring Valley, New York.
RECALLED BY Manufacturer, by letter April 21, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately (a) 11 million tablets; (b) 22 million tablets;
(c) 1.2 million tablets were distributed.
REASON Potency not assured through expiration date.
PRODUCT Erythromycin Ethylsuccinate Oral Suspension, (a) 200 mg; (b)
400 mg, in 1 pint containers, a Rx drug for the treatment of
certain infections, under the following labels: Rugby, Warner
Chilcott, Goldline. Recall #D-334/335-2.
CODE Lot numbers: (a) L2072 EXP 8/92 (Rugby/Darby), L2510 EXP 8/92
(Warner Chilcott, Lot #91989W), L3711 EXP 10/93 (Warner
Chilcott, Lot #91760W), L4060 EXP 12/93 (Warner Chilcott Lot
#917DOW), L3165 EXP 3/93 (Warner Chilcott Lot #90920W), L4125
EXP 1/94 (Warner Chilcott Lot #91821W), L5219 EXP 3/95
(Goldline); (b) L5220 EXP 2/95 (Goldline).
MANUFACTURER KV Pharmaceutical Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone April 28, 1992, followed by FAX of
recall letter dated April 29, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Ohio, New York, Pennsylvania.
QUANTITY Approximately (a) 26,648 pints; (b) 7,728 pints were
distributed; firm estimates (a) 9,000 pints; (b) 315 pints
remain on the market.
REASON Potency not assured through expiration date.
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PRODUCT (a) East India Guar Gum Soluble Dietary Fiber Capsules, 530
mg., in bottles of 100;
(b) Guar Gum, Guar Aid Gel-Forming Fiber Capsules, 500 mg, in
bottles of 200. Recall #D-336/337-2.
CODE All lots.
MANUFACTURER (a) Nature's Way Products, Inc., Springville, Utah;
(b) Twin Laboratories, Inc., Ronkonkoma, New York.
RECALLED BY General Nutrition, Inc., Pittsburgh, Pennsylvania, by notice
March 24, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Unknown.
REASON Products marketed without new drug approval.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Nolamine F.C. Tablets, time-release and film-coated, packaged
in bulk 10 gallon containers for further packaging and
labeling, Rx for use as a nasal decongestant. Recall #D-338-2.
CODE Lot #L5049.
MANUFACTURER KV Pharmaceutical Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone April 29, 1992, followed by letter
April 30, 1992. Firm-initiated recall ongoing.
DISTRIBUTION New Jersey.
QUANTITY 13 10-gallon containers containing an approximate total of
851,000 tablets were distributed.
REASON The phenindamine tartrate ingredient may not maintain potency
through expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Recovered Plasma. Recall #B-283-2.
CODE Unit numbers: 05W97663, 05KW24362.
MANUFACTURER American Red Cross Blood Services, Washington Region
(Washington Research Project), Washington, D.C.
RECALLED BY American Red Cross Blood Services, National Headquarters,
Washington, D.C., by letter March 15, 1991. Firm-initiated
recall ongoing.
DISTRIBUTION California.
QUANTITY 2 units.
REASON Blood products, collected from a donor who previously tested
repeatedly reactive for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1), were distributed.
PRODUCT Recovered Plasma. Recall #B-285-2.
CODE Unit #1291650.
MANUFACTURER University of Texas Medical Branch at Galveston (UTMB) Blood
Bank, Galveston, Texas.
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RECALLED BY Manufacturer, by telephone and by letter dated March 26, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Texas, California.
QUANTITY 1 unit.
REASON Blood product, testing repeatedly reactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), was
distributed.
PRODUCT Source Plasma. Recall #B-286-2.
CODE Unit #76793882.
MANUFACTURER Fort Smith Plasma Center, Inc., Fort Smith, Arizona.
RECALLED BY Manufacturer, by telephone March 4, 1992. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who previously tested
repeatedly reactive for hepatitis B surface antigen (HBsAg),
was distributed.
PRODUCT Red Blood Cells, Washed. Recall #B-287-2.
CODE Unit numbers: 8196183, 8208235, 8216888, 8220457, 8234009,
8236203, 8236237, 8245665, 8247545, 8249442, 8252399, 8255552,
8262502.
MANUFACTURER Southwest Florida Blood Bank, Inc., Tampa, Florida.
RECALLED BY Manufacturer, by reviewing transfusions and medical records on
March 20, 1991. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 13 units.
REASON Units of Red Blood Cells, Washed labeled with the incorrect
expiration date were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Red Blood Cells. Recall #B-162-2.
CODE Unit numbers: F27667, F38479, S60960.
MANUFACTURER San Diego Blood Bank, San Diego, California.
RECALLED BY Manufacturer, by telephone September 4, 1991 and April 19,
1991, and August 8, 1991. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 3 units.
REASON Blood products labeled with the incorrect expiration date were
distributed.
PRODUCT Red Blood Cells. Recall #B-284-2.
CODE Unit #N16315.
MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY Manufacturer, by telephone February 26, 1992. Firm-initiated
recall complete.
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DISTRIBUTION Iowa.
QUANTITY 1 unit.
REASON Blood product labeled with an incorrect expiration date and
incorrect anticoagulant was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Models MFKP and MF1500P CO2 Lasers for industrial use.
Recall #Z-309/310-2.
CODE Serial numbers: Not applicable.
MANUFACTURER Laser Ecosse Ltd., Dundee, Scotland, United Kingdom.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
January 23, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Kansas, Illinois, Michigan.
QUANTITY 4 units were distributed.
REASON Noncompliance with the performance standard for laser products
in that they lacked adequate shielding on the protective
housing, resulting in x-ray emission from the high voltage
switching tube to excess the collateral radiation limit given.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT COULTER STKS with Auto Reporter 3, used for measuring various
white blood cell differentials. Recall #Z-662-2.
CODE All units used in conjunction with the Auto Reporter 3.
MANUFACTURER Coulter Corporation, Hialeah, Florida.
RECALLED BY Manufacturer, by letters of November 27, 1992 and January 10,
1991. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 171 units were distributed.
REASON Action limits high/low codes generated for five parameters --
%s (LY, MO, NE, EO, and BA) were not printed by the Auto
Reporter 3 with the S1 2 reporting units format selected in the
STKS DMS.
PRODUCT COULTER* Hematology Analyzers, S plus IV, S plus V, ST, STKR,
and STKS, used for various blood tests. Recall #Z-680-2.
CODE Serial numbers: J39339 through S23027, R853201 through
R903917, 000000 through 518312.
MANUFACTURER Coulter Corporation, Hialeah, Florida.
RECALLED BY Manufacturer, by letter October 18, 1990. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,858 units were distributed.
REASON The auxiliary outlet reversed polarity in the pneumatic power
supply utility AC receptacle of various Coulter automated blood
chemistry/hematology testing systems.
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RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT (a) Coopers Dermathycin (thyroid stimulating hormone), Rx
subcutaneous administration for dogs, manufactured for Coopers
Animal Health, Inc.;
(b) Trimethoprim/sulfadiazine 24% and 48% injectable, in 30 ml
vials, Rx subcutaneous administration, for use in dogs where
potent systemic antibacterial action against sensitive
organisms is required. Trimethoprim manufactured for Coopers
Animal Health, Inc.;
(c) Di-trim 24% and 48% Injectable, in 30 ml vials, Rx
subcutaneous administration, for use in dogs where potent
systemic antibacterial action against sensitive organisms is
required. Manufactured for
Syntex Animal Health;
(d) Flucort (flumethasone) Solution (injectable), in 100 ml
vials, an Rx injection in equine, canine, feline species for
various rheumatic, allergic, dermatologic, and other disease
states which are known to be responsible to the
anti-inflammatory corticoids, manufactured for Syntex Animal
Health;
(e) Calphosan Suspension (intramuscular injection), in 240 ml
vials, Rx intramuscular injection for use as an aid in the
supportive treatment of milk fever in cattle, manufactured for
Glenwood, Inc.;
(f) Phosphan Solution 20%., in 100 ml vials, OTC, I.V. or deep
muscular injection, for use as a supplemental source of
nutritional phosphorus while the ration is being corrected in
areas where feeding rations are inadequate to supply all
phosohorus needs for cattle manufactured for Hoechst Roussel
Agri-Vet Company.
Recall #V-031/036-2.
CODE All lots.
MANUFACTURER Pitman-Moore, Inc., Kansas City, Kansas.
RECALLED BY Manufacturer, by letter March 13, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Denmark, Canada.
QUANTITY (a) 36,160 vials; (b) 205,407 vials; (c) 336,775 vials; (d)
42,331 vials; (e) 5,821 vials; (f) 22,656 vials were
distributed.
REASON Lack of sterility assurance due to good manufacturing practice
deficiencies.
PRODUCT Neomycin Solution, for oral or topical use, in 16 fluid ounce
and 1 gallon containers, for the treatment of bacterial
diarrhea and enteritis in beef and nonlactating dairy cattle,
swine, sheep, horses, poultry, and dogs when caused by
organisms susceptible to neomycin under the following labels:
Veterinary Laboratories, Premier Farmtech, Durvet, Agri
Laboratories, Polydex Pharmaceuticals and Vet Labs Ltd.
Recall #V-037-2.
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CODE Lot numbers 910220-1 EXP 5/92, 910444 EXP 8/92.
MANUFACTURER Veterinary Laboratories, Inc., Lenexa, Kansas.
RECALLED BY Manufacturer, by letter April 16, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,395 1-pint and 143 1-gallon containers of lot 910220 and
4,181 1-pint and 1,413 1-gallon containers of lot 910444 were
distributed.
REASON Product is contaminated with bacteria.
PRODUCT Chloramphenicol Capsules - 100 mg, 250 mg and 500 mg, a Rx
veterinary drug under the following labels: Veterinary
Pharmaceuticals, Henry Schein, Vedco; The Butler Company; Tech
America Group, Burns Veterinary. Recall #V-038-2.
CODE Lot numbers: 0A390GG, 0A390GQ, 9C390EU, 9C390EV, 81390EL,
81390EM, 8D390DL, 8C390CO, 7K390DN, 0B386GL, OA387GF, 7K387BZ,
9H386BT, 81386DC, 8C386CN, 7L386AS, 78386BY, 7G386EA, 7N3865O,
0A387GE, 9C387BK, 9C387CZ, 7L387AQ, 7L387AR, 7K387CA, 7L387AP,
7G387EC, 7G387EB, 7N38752, 7N38751, 0A387GP, 7K387CB
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Nylos Trading Company, Inc., Pomona, New York, by letter April
20, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 100 mg: 5,500,000 capsules; 250 mg: 16,000,000 capsules
500 mg: 36,000,000 capsules were distributed.
REASON Product failed dissolution testing; changes were made to the
manufacturing process without an approved supplemental NADA;
and, Barr Laboratories is unable to provide batch records for
one of the lots.
MEDICAL DEVICE SAFETY ALERTS
PRODUCT Hospal High-flux Dialyzers for Hemodialysis which includes the
following models:
(a) Filtral 12; (b) Filtral 16; (c) Filtral 20;
(d) Biospal 1800S; (e) Biospal 2400S; (f) Biospal 3000 GS;
(g) Hemospal Kit A1; (h) Hemospal Kit A1D; (i) Hemospal Kit A0;
(j) Hemospal Kit B22. Safety Alert #M-043/052-2.
CODE All lots.
MANUFACTURER CGH Medical, Inc., Lakewood, Colorado.
ALERTED BY Manufacturer, by letter April 10, 1992.
DISTRIBUTION Nationwide.
QUANTITY 39,126 units were distributed.
REASON There is the potential for anaphylactic reactions to occur in a
dialysis facility when patients maintained on angiotension
converting enzyme (ACE) inhibitors are dialyzed with hi-flux
dialyzers, which includes the firm's Filtral and Biospal
Hi-flux dialyzers.
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PRODUCT Puritan Bennett Pulse Oximetry Monitoring Option for the
Puritan Bennett 7200A Ventilator. Safety Alert #M-053-2.
CODE Part #026607. All units.
MANUFACTURER OHMEDA, Louisiville, Colorado (component).
RECALLED BY Puritan Bennett corporation, Carlsbad, California, by letter
September 4, 1990. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,147 units were distributed.
REASON If probes, other than the standard hardshell probe are used,
they may overheat and burn the patient.
SEIZURES
PRODUCT Canned Sardines (92-660-683).
FIRM Stinson Seafood Co., Stonington, Maine, and Prospect Harbor,
Maine.
CHARGE Adulterated - The products were prepared and packed under
insanitary conditions whereby they may have become contaminated
by filth.
FILED April 22, 1992 - U.S. District Court for the District of Maine;
Civil #92-0070-B; FDC #66405.
SEIZED April 24, 1992 - 16,594 cases of sardines, valued at
approximately $150-200,000.
PRODUCT Stuffed Egg Plant (92-661-259).
CHARGE Adulterated - Product consists in part of a putrid and
decomposed substance and it is unfit for food because it is
held in leaking containers.
FIRM Ziyad Brothers, Div. of Syrian Bakery and Grocery Company, Inc.,
Chicago, Illinois
FILED May 6, 1992 - U.S. District Court for the Eastern District of
Illinois; Civil #92C2979, FDC #66424.
SEIZED May 6, 1992 - goods valued at approximately $2,564.
DISPOSITIONS: PROSECUTION
DEFENDANT Mohammed F. Azeem, former Vice President of Technical Services,
Superpharm Corporation, Bayshore, New York.
CHARGE Mr. Azeem was convicted by a Federal jury of three felony
counts of making false statements to FDA in connection with
generic drug applications. He was sentenced to three years
imprisonment on each of three felony counts, the sentences to
run concurrently. In 1990, Mr. Azeem was convicted, sentenced
to, and served six months in prison for making unlawful
payments to FDA officials.
DISPOSITION January 27, 1992 - Federal jury trial; May 1, 1992 -
Sentencing; U.S. District Court for the District of Maryland;
Criminal #Har-91-0132, FDC #66537.
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DEFENDANT Muhammed Z. Mannan, former manager of the research and
development department, Superpharm Corporation, Bayshore,
New York.
CHARGE A federal jury found Mr. Mannan to be guilty of submitting
false information to the FDA in support of Superpharm's generic
drug applications. He was sentenced to serve four months in a
halfway house.
DISPOSITION January 27, 1992 - Federal jury trial; May 1, 1992 -
Sentencing; U.S. District Court for the District of Maryland;
Criminal #Har-91-0132; FDC #66537.
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END OF ENFORCEMENT REPORT FOR MAY 13, 1992. BLANK PAGES MAY FOLLOW.
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