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
04/10/1990
FDA Enforcement for the week of April 11, 1990
FDA ENFORCEMENT REPORT
FOR APRIL 11, 1990
April 11, 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.
Product: All L-tryptophan products not covered by 21 CFR 172.320
or by a current IND, from all levels of distribution.
Recall #F-456-0. An extension of Recall #F-140-0 which
appeared in the January 17, 1990 Enforcement Report.
Code: All lots.
Manufacturer: All manufacturers, distributors and repackers.
Recalled by: On March 22, 1990, the Food and Drug Administration issued
a press release (P90-21) and a video release which announced
that the Agency is requesting manufacturers, repackers, or
own-label distributors to recall all manufactured
L-tryptophan containing products in tablet, capsule,
caplet, powdered or liquid form, along with multi-
ingredient, non-protein supplements that also contain
L-tryptophan.
-1-
distribution. FDA requested recall ongoing.
Distribution: Nationwide.
Quantity: Unknown large quantity.
Reason: Eosinophilia-myalgia syndrome attributed to L-tryptophan
containing products.
----
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: Noah's Cheezettes packed in 1 ounce and 7 ounce poly bags.
Recall #F-457-0.
Code: The firm uses a 21 day freshness expiration date. Any
package that does not declare the presence of FD&C Yellow
#5 and #6 is under recall.
Manufacturer: Noah's Potato Chip Company, Inc., Alexandria, Louisiana.
Recalled by: Manufacturer, by letter November 30, 1989. Firm-initiated
field correction complete.
Distribution: Louisiana.
Quantity: Firm estimates none remains on market.
Reason: Product lacks a color declaration and contains undeclared
Yellow No. 5.
----
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
Product: Nature's Sunshine Products brand Tofu Moo Carob, a
non-dairy dried tofu beverage mix, in 27.6 ounce cans.
Recall #F-458-0.
Code: Lot numbers 9100E, 9100F.
Manufacturer: Great American Foods, Inc., Salt Lake City, Utah.
Recalled by: Nature's Sunshine Products, Inc., Spanish Fork, Utah,
by telephone February 14, 1990 followed by letter February
16, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 420 cans were distributed.
Reason: Product is contaminated with small round metal particles.
----
COSMETICS
NONE
-2-
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Source Plasma. Recall #B-122-0.
Code: Unit numbers: 9810, 9914, 10072, 10218, 10467, 10597,
10827, 10945, 11152, 11301, 11534, 11728, 11898, 12151,
12427, 12557.
Manufacturer: Yale Blood Plasma, Inc., Albuquerque, New Mexico.
Recalled by: Manufacturer, by letter March 29, 1989. Firm-initiated
recall ongoing.
Distribution: New York, Japan.
Quantity: 16 units were distributed.
Reason: Units of Source Plasma drawn from a donor who previously
tested repeatably reactive for the hepatitis B surface
antigen (HBsAg) were distributed.
----
Class III -
Product: Recovered Plasma. Recall #B-117-0.
Code: Unit #06GF51181.
Manufacturer: American Red Cross Blood Services, Los Angeles, California.
Recalled by: Manufacturer, by telephone June 26, 1989. Firm-initiated
recall complete.
Distribution: California.
Quantity: 1 unit was distributed and destroyed.
Reason: Recovered Plasma, which tested nonreactive for the
Hepatitis B Surface Antigen (HBsAg) but was collected from
a donor who previously tested reactive for HBsAg, was
distributed.
----
MEDICAL DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Datascope Intra-Aortic Balloon Pump (IABP)- System 90,
the pump, a critical device is coupled with an intra-aortic
balloon catheter which is inserted into the patient's aorta.
Recall #Z-138-0.
Code: Product #0998-00-0010-XX, serial numbers range from 1001
through 1614, inclusive; Product #0998-00-0058-XX, serial
numbers range from 2000 through 3181, inclusive.
-3-
Manufacturer: Datascope Corporation, Paramus, New Jersey.
Recalled by: Manufacturer, by letter February 7, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 2,200 units were distributed.
Reason: The System 90 (IABP) power supply board may fail.
----
Product: Biosearch Pedi Tube Pediatric Nasal Gastric Feeding Tube.
Recall #Z-458-0.
Code: Product #14-7318, batch lot #8821, G-80.
Manufacturer: Biosearch Medical Products, Inc., Somerville, New Jersey.
Recalled by: Manufacturer, by telephone between August 25, 1989 and
August 29, 1989. Firm-initiated recall ongoing.
Distribution: California, Maine, Wisconsin, New Jersey, Florida,
Pennsylvania, Michigan, Massachusetts, South Carolina,
Canada.
Quantity: 700 units consisting of 10 tubes each were distributed.
Reason: There is a potential for a leak to develop at the bond
between the luer connector and the feeding tube which
could weaken the connection and allow the luer to detach.
----
Product: Hygroscopic Cervical Dilator - Dilapan (tm)
4 mm x 55 mm, a sterile Class III medical device
indicated for dilation of the cervix prior to termination
of pregnancy up to 16 weeks gestation. Recall #Z-460-0.
Code: Lot numbers: D070389, D092989.
Manufacturer: Gynotech, Inc., Middlesex, New Jersey.
Recalled by: Manufacturer, by telex December 8, 1989 and by telephone
December 18, 1989. Firm-initiated recall ongoing.
Distribution: Minnesota, Texas, California, Ohio, Japan.
Quantity: 1,725 dilators were distributed.
Reason: The device is labeled as sterile, however, firm failed
to satisfactorily document that lots D070389 and D092989
had in fact been sterilized.
----
Product: Instascreen CHAP Kit, an in-vitro diagnostic test system
designed to detect the presence of cocaine, heroin/morphine,
amphetamines, PCP and their metabolites in urine.
Recall #Z-461-0.
Code: Lot numbers: 61-04049, 65-04279, 65-06129, 65-05159,
65-08189, 65-09089, 61-10070.
Manufacturer: Drug Screening Systems, Inc., Blackwood, New Jersey.
Recalled by: Manufacturer, by letter on or about October 26, 1989.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, The Phillipines.
Quantity: 5,402 kits were distributed.
-4-
Reason: The kits exhibit variability in product performance over
time. As a consequence the use of this product may give a
false negative.
----
Product: Quad Ferm +, for in-vitro diagnostic use, for the rapid
determination carbohydrate utilization, DNase activity
and Penicillinase activity by organisms belonging to the
genera Neisseria and Branhamella. Recall #Z-463-0.
Code: Product #8886-301020, Lot #1807F9.
Manufacturer: API Analytab Products, Plainview, New York.
Recalled by: Manufacturer, by letter August 30, 1989. Firm-initiated
recall ongoing.
Distribution: Nationwide, France, Italy.
Quantity: 456 kits were distributed.
Reason: The substrates DNase and Beta-Lactamase were filled in
reverse order such that DNase was filled in the Beta-
Lactamase well and vice-versa.
----
Class III -
Product: Amerlite TBG (Thyroid Binding Globulin) EIA Kit, an
in-vitro diagnostic for the quantitative measurement of
thyroxine-binding globulin (TBG) in human serum or
plasma. Recall #Z-457-0.
Code: Product codes: LAN.0005 and LAN.2005, lot numbers 30 and 32
EXP 7/23/90.
Manufacturer: Amersham International plc, Cardiff, Wales, UK.
Recalled by: Amersham Corporation, Arlington Heights, Illinois, by
telephone March 5, 1990 followed by
visit. Firm-initiated recall ongoing.
Distribution: Massachusetts, Connecticut, Maryland, Florida, Tennessee,
California.
Quantity: 26 kits were distributed; firm estimates 14 kits remain
on market.
Reason: Some of the "D" Standard 20 (mg/l) vials were mislabeled
with "F" Standard (80 mg/l) labels.
----
Product: Instascreen Cannabinoid Kit, an in-vitro diagnostic test
system designed to detect the presence of marijuana,
hashish, THC and their derivatives in urine.
Recall #Z-459-0.
Code: Lot numbers: 51-05159, 55-05049, 55-05029, 55-05039,
51-01279, 51-01069, 55-02009, 51-01199, 51-01269,
51-02169, 51-03019, 51-04209, 51-03309, 51-04269.
Manufacturer: Drug Screening Systems, Inc., Blackwood, New Jersey.
Recalled by: Manufacturer, by telephone July 1989 followed by letter.
Firm-initiated recall ongoing.
-5-
Distribution: Nationwide, Canada, Phillipines.
Quantity: Approximately 5,416 kits were distributed.
Reason: The device may exhibit variability in product performance
over time. As a consequence the product may give a false
positive test result.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Chloramphenicol Capsules, 250 mg. each, packaged 8
capsules in foam cut-out insert inside a clear plastic box,
an OTC drug for aquarium use only, labeled to control and
cure bacterial infections in marine fish. Recall #V-037-0.
Code: Lot numbers 673 through 681 (all lots).
Manufacturer: Barr Laboratories, Northvale, New Jersey.
Recalled by: Silco Pet Products, Inc., Alexandria, Virginia, by letters
the week of March 13, 1990. Firm-initiated recall ongoing.
Distribution: Washington, D.C., Maryland, Virginia, New York, Florida.
Quantity: Firm estimates less than 1,000/8 capsule packs remain on
market.
Reason: Chloramphenicol for OTC aquarium use is an unapproved
new animal drug.
----
Class III -
NONE
Seizure Actions Filed:
Product: Frozen Shrimp (90-510-972).
Charge: Misbranded - Product is short weight.
Firm: Macau Frozen Food Company, Ltd., Pereira Marquez, Macau.
Filed: February 7, 1990 - U.S. District Court for the District
of Puerto Rico; Civil #90-1186(JAF), 65806.
----
Product: Ventilation Tubes for Otology (89-457-548).
Charge: Adulterated - Products were prepared, packed and held
under conditions not in conformity with good manufacturing
practice regulations; Misbranded - Labeling fails to bear
adequate directions for use.
Firm: Anthony Products, Inc., Indianapolis, Indiana.
Filed: February 15, 1990 - U.S. District Court for the Southern
District of Indiana; Civil #1P90149C, FDC #65781.
----
-6-
Product: Neomycin Sulfate Sterile Powder (90-601-545).
Charge: Misbranded antibiotic drug -- No certificate or
release has been issued.
Firm: Pharma-Tek Inc., Northport, New York.
Filed: February 26, 1990 - U.S. District Court for the Eastern
District of New York; Civil #CV-90-0655, FDC #65783.
----
Product: Spices (90-600-019).
Charge: Products were held under insanitary conditions
whereby they may have become contaminated with filth.
Firm: Schiff Food Products Company, Inc., Brooklyn, New York.
Filed: March 2, 1990 - U.S. District Court for the Eastern
District of New York; Civil #CV 90-0735, FDC #65834.
----
Product: All foods in rodent and insect susceptible containers.
(90-577-515).
Charge: Adulterated - Products were held under insanitary conditions.
Firm: Economy, Inc., Chicago, Illinois.
Filed: March 9, 1990 - U.S. District Court for the Northern
District of Illinois; Civil #90C-1375; FDC #65840.
----
Product: Personal Size Oxygen and Personal Oxygen Systems
(89-545-562).
Charge: Products are unapproved new drugs; fails to bear prescription
legend; labeling fails to bear adequate directions for use;
manufactured at non-registered/non-listed establishment.
Firm: Pro-Line International, Inc., Rochester, New York.
Filed: March 14, 1990 - U.S. District Court for the Western
District of New York; Civil #90-274-T, FDC #65684.