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
02/20/1990
FDA Enforcement for the week of February 21, 1990
FDA ENFORCEMENT REPORT
FOR FEBRUARY 21, 1990
February 21, 1990
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.
NONE
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Doxycycline Hyclate Capsules, 50 mg., in bottles of 50 and
500, an Rx antibiotic under the Bioline, Goldline and
Superpharm labels. Recall #D-147-0.
Code: All lots.
Manufacturer: Superpharm Corporation, Bayshore, New York.
Recalled by: Manufacturer, by letter January 15, 1990. Firm-initiated
recall ongoing.
Distribution: New York, California, Connecticut, Ohio, Florida, Texas.
Quantity: 26,036/50 capsule bottles were distributed.
Reason: Lack of assurance of bioequivalency and abbreviated New
Drug Application discrepancies.
----
Product: (a) Recovered Plasma; (b) Recovered Plasma, Pooled.
Recall #B-080/081-0.
Code: Unit numbers: (a) C7006, C7007, C7010, C7013, C7014, C7018,
C7021, C7022, C7025, C7029, C7032, C7033, C7035, C7037, C7039,
C7044, C7048, C7055, C7058, C7060, C7071, C7138, C8801, C8803,
C8874, C8875; (b) Pool numbers 3 (which includes Recovered
Plasma unit C8943); 4 (which includes Recovered Plasma, units
C8946 and C8944); 8 (which includes Recovered Plasma, units
C8949, C8948, C8756); 9 (which includes Recovered Plasma,
units C8753, C8847, C8834; 10 (which includes Recovered
Plasma, units C8759); 16 (which includes Recovered Plasma,
units C8796, C8806); 17 (which includes Recovered Plasma,
units C8792 and C8797); 18 (which includes Recovered Plasma,
unit C8814); 20 (which includes Recovered Plasma units C8834,
C8836, C8844, C8855, C8848); 22 (which includes Recovered
Plasma, units C8843, C8850, C8853); 26 (which includes
Recovered Plasma unit C7049) and 28 (which includes Recovered
Plasma units C7036, C7046, C7051, C7054).
Manufacturer: Community Hospital of Indianapolis, Indianapolis, Indiana.
Recalled by: Manufacturer, by telephone December 7, 1989 followed by
letter December 8, 1989. Firm-initiated recall complete.
Distribution: Florida.
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Quantity: Firm estimates none remains on market.
Reason: Blood components drawn from improperly screened donors
were distributed.
----
Product: Whole Blood. Recall #B-082-0.
Code: Unit #11G99752.
Manufacturer: American Red Cross, MO-Il Regional Red Cross Blood
Services, St. Louis, Missouri.
Recalled by: Manufacturer, by telephone June 29, 1989. Firm-initiated
recall complete.
Distribution: Missouri.
Quantity: 1 unit was distributed and was destroyed.
Reason: Unit of Whole Blood was distributed that was drawn from a
donor with a needlestick exposure 3 months prior to
donation.
----
Product: (a) Red Blood Cells; (b) Fresh Frozen Plasma;
(c) Platelets. Recall #B-083/085-0.
Code: Unit number J13498-0.
Manufacturer: St. Johns County Blood Bank, St. Augustine, Florida.
Recalled by: Manufacturer, by letter October 30, 1989.
Firm-initiated recall ongoing.
Distribution: Florida.
Quantity: 1 unit of each component was distributed.
Reason: Blood products were distributed that were drawn from donors
who previously tested repeatably reactive for the
antibody to the human immunodeficiency virus (anti-HIV-1).
----
Class III -
Product: Rugby brand Triple Antibiotic Ointment in 1 ounce tubes,
OTC topical indicated for the use as a first aid to
help prevent infection in minor cuts, scrapes and burns.
Recall #D-148-0.
Code: Lot #910022.
Manufacturer: Naska Pharmacal Co., Inc., Hauppauge, New York.
Recalled by: Manufacturer, by letter January 2, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 1,327 to 1,376 tubes were involved in
the mix-up.
Reason: Some unit cartons are mislabeled as Bacitracin Ointment.
----
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Product: Nitroglycerin 2.6 mg Controlled Release Tablets, in
bottles of 100 and in bulk (50,000 tablets per box),
an Rx vasodilator indicated for the prevention of
angina pectoris due to coronary artery disease.
Recall #D-149-0.
Code: Lot numbers: IV8771W EXP 5/92 (bottles), 8771E EXP 2/89
(bulk product).
Manufacturer: D.M. Graham Laboratories, Inc., Hobart, New York.
Recalled by: Rhone-Poulenc Pharmaceutical, Inc., Princeton, New
Jersey, by letter November 2, 1989 and November
9, 1989. Firm-initiated recall ongoing.
Distribution: Nationwide, Belgium, The Netherlands.
Quantity: 766/100 tablet bottles and 18/50,000 bulk containers
were distributed; firm estimates 100 bottles remain on
market.
Reason: Subpotency.
----
Product: Invamed brand Propranolol Hydrochloride Tablets, 20 mg.,
in 1,000 tablet bottles, an Rx oral cardiac depressant.
Recall #D-150-0.
Code: Lot #8M41 EXP 1/91.
Manufacturer: Invamed, Inc., Fairfield, New Jersey.
Recalled by: Manufacturer, by letter on or about January 31, 1990.
Firm-initiated recall ongoing.
Distribution: New Jersey, California, Illinois.
Quantity: 919,000 tablets were distributed; firm estimates 50
bottles remain on market.
Reason: Product does not meet content uniformity requirements.
----
Product: (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-086/087-0.
Code: Unit numbers J12513-5.
Manufacturer: St. Johns County Blood Bank, St. Augustine, Florida.
Recalled by: Manufacturer, by letter October 30, 1989.
Firm-initiated recall ongoing.
Distribution: Florida.
Quantity: 1 unit of each component was distributed.
Reason: Blood products were distributed that were drawn from
donors who previoviously tested repeatably reactive for
the hepatitis B surface antigen (HbsAg).
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
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Class II -
Product: General Purpose Lasers: (a) Model #48-1-115;
(b) Model #48-1-28; (c) Model #48-2-115.
Recall #Z-209/211-0.
Code: Not coded.
Manufacturer: Synrad, Inc., Bothell, Washington.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan October 23, 1989. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 16 units were distributed.
Reason: Noncompliance with the performance standard for laser
products in that they lacked required remote interlock
connectors and manual reset mechanism.
----
Product: Smart Monitor Models 900S, 950S, 970S, an Rx cardio-
respiratory monitor which, depending on the model, has a
memory capacity (900S has no memory capacity and 970S has
the largest memory capacity). Recall #Z-284/286-0.
Code: All lot numbers.
Manufacturer: Healthdyne Technologies, Inc., Marietta, Georgia.
Recalled by: Manufacturer, by letter and field correction package
December 11, 1989. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,184 units were distributed.
Reason: Malfunctions in the power supply circuitry, caused by
static electricity discharge, results in the monitors
failing to function, and the internal alarm not sounding.
----
Class III -
NONE
VETERINARY PRODUCTS
Class I-
NONE
Class II --
Product: Various medicated feeds in 50 pound bags:
(a) Medicated Pig Grower, "Alimentos El Agro," Tilosina
40 g/t;
(b) Medicated Broiler Starter, "Alimentos El Agro," Monensin
Sodium 100 g/t, bacitracin 25 g/t;
(c) Medicated Chick Starter, "Alimentos El Agro,: Monensin
-5-
Sodium 110 g/t;
(d) Medicated Cock Fight, "Alimentos El Agro," Bacitracin
50 g/t;
(e) Starter/Growing (Chicken), "Alimentos El Agro,"
Bacitracin 10 g/t. Recall #V-025/029-0.
Code: All lots.
Manufacturer: Agro Ochoa, Inc., Guaynabo, Puerto Rico.
Recalled by: Manufacturer, by telephone December 15, 1989. Firm-
initiated recall ongoing.
Distribution: Puerto Rico.
Quantity: (a) 2,434 bags; (b) 65 bags; (c) 95 bags; (d) 465 bags;
(e) 537 bags were distributed.
Reason: The products were not manufactured in conformance with
current good manufacturing practice, they may not contain
the drug they are represented to contain, and they may be
subpotent or superpotent.
----
Seizure Actions Filed:
Product: Latex Examination Gloves (90-552-584).
Charge: Adulterated - Product contains holes;
Mislabeled - Labeling fails to bear name and place of
business of manufacturer, packer or distributor.
Firm: Scitech Medical Products, Inc., New Hyde Park, New York.
Filed: November 28, 1989 - U.S. District Court for the Western
District of Missouri; Civil #89-1108-CV-W-3, FDC #65776.
----
Product: Basmati Rice (89-566-970).
Charge: Adulterated - Product contains insect, rodent and
bird filth.
Firm: House of Spices, Buena Park, California.
Filed: November 29, 1989 - U.S. District Court for the Central
District of California; Civil #89-6894, FDC #65782.
----
Product: Chick Peas, Split Beans, Rice and Spices (90-576-444).
Charge: Products were held under insanitary conditions.
Firm: Jai Hind Corporation, Chicago, Illinois.
Filed: December 5, 1989 - U.S. District Court for the
Northern District of Illinois, Civil #89-C-8977,
FDC #65792.
----
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Product: Foods in insect susceptible containers (90-526-663).
Charge: Products were held under insanitary conditions.
Firm: Cauble and Field, Inc., Cape Girardeau, Missouri.
Filed: December 7, 1989 - U.S. District Court for the
Eastern District of Missouri; Civil #S89-0182-C,
FDC #65786.
----
Product: All foods in insect susceptible containers (90-566-488).
Charge: Adulterated - Products contain insects.
Firm: PFC Foods, Inc., Los Angeles, California.
Filed: December 11, 1989 -- U.S. District Court for the Central
District of California; Civil #89-7136, FDC #65787.
----
Product: Latex Examination Gloves (89-455-605).
Charge: Adulterated - Product contains holes; Misbranded -
Labeling fails to bear name and place of business of
manufacturer, packer, or distributor.
Firm: Voit Sports, Fairport, New York.
Filed: December 14, 1989 - U.S. District Court for the District
of Nevada, Reno Division; Civil #CV-N-89-791-BRT,
FDC #65789.
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Product: All Foods in rodent susceptible containers (90-576-684).
Charge: Products were held under insanitary conditions.
Firm: New Way Trading, Inc., Chicago, Illinois.
Filed: February 5, 1990 - U.S. District Court for the
Northern District of Illinois, Eastern Division;
Civil #90-C-0642(Judge Shadur), FDC #65820.