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
12/04/1991
Recalls and Field Corrections: December 4, 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: Gulf Coast Crabmeat, Inc., refrigerated crabmeat in
16 ounce plastic cups: (a) Special Crabmeat;
(b) Claw Crabmeat; (c) Backfin Crabmeat.
Recall #F-053/055-2.
Code: None.
Manufacturer: Gulfcoast Crabmeat, Inc., Panama City, Florida.
Recalled by: Manufacturer, by telephone October 28, 1991. Firm-
initiated recall complete.
Distribution: Maryland, Florida.
Quantity: Firm estimates none remains on the market.
Reason: Product is contaminated with Listeria monocytogenes.
----
-1-
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.
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Class III -
Product: Rectagene II Medicated Rectal Suppositories, used to
relieve hemorrhoidal pain and burning. Recall #D-096-2.
Code: 9135-3 EXP 6/92.
Manufacturer: G & W Laboratories, South Plainfield, New Jersey.
Recalled by: Pfeiffer Pharmaceutical, Inc., Wilkes Barre, Pennsylvania,
by telephone October 10 and 11, 1991. Firm-initiated recall
ongoing.
Distribution: California, Florida, Illinois, Indiana, Michigan,
Mississippi, New Jersey, New Mexico, New York, Ohio,
Oklahoma, Wisconsin.
Quantity: Firm estimates 345 boxes (12 units per box) remain on
the market.
Reason: Product distributed after August 5, 1991 is not in
compliance with regulations for OTC anorectal drug products.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
Class II -
Product: Intertech/Inspiron Medication Nebulizer Kits:
(a) Intertech/Inspiron Medication Nebulizer Kit with Aerosol
"T", Mouthpiece and "Fits-all" Universal Oxygen Tubing;
(b) Intertech/Inspiron Medication Nebulizer Kit with
-2-
Aerosol "T", Mouthpiece, Flex Tube and "Fits-all" Universal
Oxygen Tubing. Recall #Z-127/128-2.
Code: (a) Catalog Number 007761, Lot Number DBBU00208;
(b) Catalog Number 007763, Lot Numbers DBDU00206 DBDU00306.
Manufacturer: Intertech Resources, Inc., Fort Myers, Florida.
Intertech Resources, Inc., Lincolnshire, Illinois.
Recalled by: Manufacturer, by telephone April 10, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and The Netherlands.
Quantity: Approximately 2,155 cases (50 units per case) were
distributed.
Reason: The nebulization flow rate for some kits was lower than
normal.
----
Product: MEVATRON medical linear accelerators, digital controlled
versions for x-ray and electron radiation therapy:
(a) MEVATRON Medical Linear Accelerator, Model Series M2;
(b) MEVATRON Medical Linear Accelerator, Model Series KD2.
Recall #Z-129/130-2.
Code: Serial numbers: 1772, 1874, 1901, 1911, 1935, 1938, 1941,
1944, 1949, 1966, 1987, 1784, 1881, 1974, 1976, 1981, 1803,
1821, 1918, 1718, 1825, 1876, 1894, 1912, 1928, 1989.
Manufacturer: Siemens Medical Laboratories, Inc., Concord, California.
Recalled by: Manufacturer. FDA approved the firm's corretive
action plan April 4, 1990. Firm-initiated field correction
complete.
Distribution: California, Georgia, Illinois, Massachusetts,
North Carolina, Ohio, Texas, Canada, United Kingdom,
The Netherlands, Germany.
Quantity: 26 units.
Reason: Design deficiency in accessory interlocks allowed patients
to be exposed to x-rays when electron beams were the
intended treatment mode.
----
Class III -
Product: Sodium Chloride 0.85% (0.15M NaCl), saline solution, in
polyethylene bag within corrugated cardboard outer box,
containing 20 liters of saline, suitable for
immunohematological use. Recall #Z-123-2.
Code: Catalog #S100G, Lot #1017.
Manufacturer: Biochemical Sciences, Inc., Bridgeport, New Jersey.
Recalled by: Manufacturer, by letter March 22, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 285 boxes were distributed.
Reason: A weak false positive reaction described as the
appearance of a reddish-brown color and micro-agglutination
of red blood cells in an Anti-D Blood Grouping Reagent
was reported.
----
-3-
Product: Repliplate Cathra 16 mcg/ml Cefazolin (CZL) Antibiotic
Media Plates, used for in-vitro testing of patient
serum. Recall #Z-124-2.
Code: Lot #08060CZL16.
Manufacturer: AutoMed, Inc., Shoreview, Minnesota.
Recalled by: Manufacturer, by telephone August 16, 1990. Firm-initiated
recall ongoing.
Distribution: Canada.
Quantity: 20 plates were distributed.
Reason: The product was formulated to a concentration of 32
micrograms/ml rather than 16 micrograms/ml.
----
Product: CRP-Reactive Protein Kit, an in-vitro diagnostic for
detection of C-reactive protein associated with
inflammation or necrosis. Recall #Z-125-2.
Code: Lot #1220T001A1 EXP 6/1/90.
Manufacturer: Texas Immunology, Inc., Division of V-Tech, Inc.,
Tyler, Texas.
Recalled by: V-Tech, Inc., Pomona, California, by letter October 24,
1989. Firm-initiated recall complete.
Distribution: California.
Quantity: 1,987 kits were distributed; firm estimates none
remains on the market.
Reason: The test may give false positive results.
----
Product: Sera-Tek MHA-TP (Treponemal Antibody Test),
Product Code 2910. Recall #Z-126-2.
Code: Control #0621051 EXP 12/92.
Manufacturer: Fujirebio, Inc., Tokyo, Japan.
Recalled by: Miles, Inc., Diagnostics Division, Mishawaka, Indiana,
by letter September 13, 1991, followed by telephone
October 1, 1991. Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 339 kits were distributed; firm estimates 74 kits
remain on the market.
Reason: The product may yield false positive results.
----
VETERINARY PRODUCTS
NONE
-4-
Medical Device Safety Alerts:
Product: Olympus REPLY Analyzer Software, Version 2.5.
Safety Alert #M-006-2.
Code: All units of the software Catalog #ZM1599, Version 2.5.
Manufacturer: Olympus Optical, Ltd., Tokyo, Japan.
Alerted by: Olympus Corporation, Lake Success, New York, by letter
July 2, 1991.
Distribution: Nationwide.
Quantity: 52 units were distributed.
Reason: If a specific testing sequence occurs while using the
STAT analysis, the resulting data output may contain the
incorrect accession numbers and test run.
----
Prosecution Action Filed:
Against: Mary L. Donnelly, Bay City, Michigan.
Product: Prescription Drug Sample - Zantac 150 (91-555-054).
Charge: No person may sell, purchase, or trade or offer to
sell, purchase, or trade any drug sample.
Filed: October 24, 1991 - U.S. District Court for the Eastern
District of Michigan, Northern Division;
Criminal #92-CR-20064BC.
-5-
###