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
07/27/1994
Recalls and Field Corrections: Foods -- Class I -- 07/27/1994
July 27, 1994 94-30
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT C. Ochoa White Cheese in 8 and 12 ounce vacuum packed
plastic packages. Recall #F-737-4.
CODE One uncoded lot manufactured March 29, 1994.
MANUFACTURER C. Ochoa Cheese, Brownsville, Texas.
RECALLED BY Manufacturer, by visit April 4 and 5, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY Firm estimates none remains on the market.
REASON Product had the potential to support the outgrowth of
Clostridium botulinum toxin.
_______________
PRODUCT Pepperidge Farm Goldfish Snack Mix Nutty Deluxe with Honey
Roasted Cashews/Almonds, in 9-1/4 ounce cartons.
Recall #F-738-4.
CODE All pull dates through Sell By 10/07/94.
MANUFACTURER Pepperidge Farm, Inc., Willard, Ohio.
RECALLED BY Pepperidge Farm, Inc., Norwalk, Connecticut, by press
release May 27, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and the Caribbean.
QUANTITY Approximately 14,000 to 15,000 cases (24 boxes per case).
REASON Product contains nuts which were roasted in cold pressed
peanut oil and the label fails to declare the peanut oil
ingredient.
_______________
PRODUCT Hot Smoked Catfish Fillets, random weights, in either vacuum
packed plastic bags, vacuum packed plastic/foil bags or
loose in a box. Recall #F-739-4.
CODE 41223 and 41263.
MANUFACTURER Horton's Downeast Foods, Inc., Waterboro, Maine.
RECALLED BY Manufacturer, by telephone May 31, 1994, followed by letter
June 1, 1994. Firm-initiated recall complete.
DISTRIBUTION Maine, Florida, New York, Massachusetts.
QUANTITY 21.16 pounds were distributed.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Cold Smoked Tuna, placed on foil/cardboard support vacuum
packed in plastic, wholesale size 1-3 pounds and retail size
4 ounces. Recall #F-740-4.
CODE Lot numbers: 11092, 11095, 911092, 121092, 911222, 910952.
MANUFACTURER Horton's Downeast Foods, Waterboro, Maine.
RECALLED BY Manufacturer, by telephone May 18 1994, followed by letter.
Firm-initiated recall complete.
DISTRIBUTION Florida, Massachusetts, Maine, Missouri, North Carolina, New
Hampshire, New York, Texas.
QUANTITY 196.55 pounds were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Keebler Zesty Meal Ground Saltine Crackers, in 15 pound
cartons. Recall #F-741-4.
CODE Lot numbers: 080E, 081F, 081D, 081E, 082F, 082D, 083F,
083E, 084F (manufactured 3/21-25/94).
MANUFACTURER Keebler Company, Denver, Colorado.
RECALLED BY Keebler Company, Elmhurst, Illinois, by letter June 21,
1994, by fax and telephone June 22, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Iowa, Mississippi, New Jersey, Maryland, Pennsylvania,
Florida, Indiana, Kentucky, Ohio, Tennessee, Texas,
Minnesota, New Mexico.
QUANTITY 770 cases were distributed; firm estimates less than 20%
remains on the market.
REASON Product contains pieces of metal and plastic.
_______________
PRODUCT Sutliff's Creme Candy Wafers, in 1 pound and 2 pound boxes
in the following colors and flavors: (a) Yellow; (b)
Orchid; (c) Pink; (d) Apricot; (e) Ivory.
Recall #F-743/747-4.
CODE None.
MANUFACTURER Sutliff Candy Company, Inc., Seattle, Washington.
RECALLED BY Manufacturer, by telephone June 15, 1994. Firm-initiated
recall complete.
DISTRIBUTION Washington state.
-2- QUANTITY Firm estimates none remains on the market.
REASON Products contained undeclared FD&C Yellow #5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Salted-In-Shell Sunflower Seeds, in 9.5 ounce plastic bags.
Recall #F-742-4.
CODE 13C4113, 14C4113, 17C4113, 18C4113, 19C4113, 21C4113,
23C4113, 25C4113, 13P4113, 18P4113, 22P4113, 12R4113,
15R4113, 18R4113, 21R4113, 23R4113, and 24R4113.
MANUFACTURER Sathers Inc., Round Lake, Minnesota (repacker).
RECALLED BY Repacker, by telephone June 29, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and Chile.
QUANTITY 4,620 cases (12 bags per case) were distributed.
REASON Product bears an incorrect ingredient statement.
_______________
PRODUCT Sutliff Creme Candy Wafers, Blue, in 1 pound and 2 pound
boxes. Recall #F-748-4.
CODE None.
MANUFACTURER Sutliff Candy Company, Inc., Seattle, Washington.
RECALLED BY Manufacturer, by telephone June 15, 1994. Firm-initiated
recall complete.
DISTRIBUTION Washington state.
QUANTITY Firm estimates none remains on the market.
REASON Product contains undeclared FD&C Blue #1.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Slo-Phyllin 80 mg Syrup (Theophylline), in 16 fluid ounce
glass bottles, taken orally for asthmatic relief.
Recall #D-332-4.
CODE Lot #89559 EXP 5/95.
MANUFACTURER Rhone-Poulenc Rorer, Fort Washington, Pennsylvania.
RECALLED BY Rhone-Poulenc Rorer, Collegeville, Pennsylvania, by letter
June 13, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,931 bottles were distributed.
REASON Potency is marginally above the upper specification limit of
107%.
_______________
PRODUCT Sterile Aerosol Talc Spray, in 4 g. cans, used for recurrent
or persistent pneumothorax and recurrent or persistent
pleural effusions. Recall #D-333-4.
CODE All lots.
MANUFACTURER Talc de Luzenac, Cedex-France.
RECALLED BY Bryan Corporation, Woburn, Massachusetts, by letter July 15,
1994. Firm-initiated recall ongoing.
-3- DISTRIBUTION Nationwide.
QUANTITY Approximately 2,000 units.
REASON Product marketed without new drug approval.
_______________
PRODUCT Baker Norton brand Proglycem (diazoxide, USP) 50 mg
capsules, in bottles of 100, used for treatment of chronic
hypoglycemia. Recall #D-334-4.
CODE Lot #4C01871 EXP 3/96.
MANUFACTURER Baker Norton Pharmaceuticals, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter July 12, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 429 bottles were distributed.
REASON Product does not meet content uniformity specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Cardiotec Kit for the preparation of Technetium Tc 99m
Teboroxime, a radioactive diagnostic. Recall #D-330-4.
CODE Lot 2F48395 of the formulation was packaged as three kits:
List #03206, lot #2F48395 (10 vials per kit);
List #03205, lot #2F49441 (5 vials per kit);
List #03207, lot #2F49452 (25 vials per kit).
MANUFACTURER Bristol-Myers Squibb Company, New Brunswick, New Jersey.
RECALLED BY Bristol-Myers Squibb Company, Princeton, New Jersey, by
telephone December 9, 1993, followed by letter December 10,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 4,110 vials were distributed.
REASON Vials may not meet the reconstituted physical appearance
description as stated in the package insert.
_______________
PRODUCT H.L. Moore brand Diazepam Tablets, USP 5 mg in bottles of
100, indicated for the management of anxiety disorders or
for the short-term relief of the symptoms of anxiety.
Recall #D-331-4.
CODE Lot #3926-1014 EXP 4/96.
MANUFACTURER Zenith Laboratories Caribe, Inc., Cidra, Puerto Rico.
RECALLED BY Manufacturer, by telephone June 2, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Connecticut, Illinois.
QUANTITY 216 bottles were distributed; firm estimates none remains on
the market.
REASON A shipment erroneously contained package outserts for
Prazosin.
-4-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Tech Attach Connection Systems, EEG cables that can be
purchased separately or as part of a Wyler Sphenoidal
Electrode package. Recall #Z-890-4.
CODE All lots/codes of the Tech Attach Connection Systems,
distributed prior to 12/1/93. All models with unprotected
electrode lead wires.
MANUFACTURER Ad-Tech Medical Instrument Corporation, Racine, Wisconsin.
RECALLED BY Manufacturer, by letter sent on or about December 1, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,368 cables.
REASON Product labeling fails to provide adequate directions for
use and the devices pose an unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.
_______________
PRODUCT Siemens Conventional Mevatron Linear Accelerator System,
equipped with an electron high dose rate (HI-E) mode and/or
electron rotational therapy (EL-ROT) mode, used in the
treatment of cancer with radiation. Recall #Z-1098-4.
CODE All lots.
MANUFACTURER Siemens Medical Systems, Inc., Oncology Care Systems,
Concord, California.
RECALLED BY Manufacturer, by letter February 11, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 100 units.
REASON In the Hi-E or EL-ROT mode, the display gives a decimal
shift of one place to the right. If not changed, the dose
delivered will be ten times too much.
_______________
PRODUCT MicroScan Rapid Positive Combo Type I, used for
identification to species level and/or antimicrobial
susceptibility of facultative and some fastidious aerobic
gram-positive cocci and limonocytognes. Recall #Z-1110-4.
CODE Catalog #B1017-23, lot #09AUG93.
MANUFACTURER Baxter Diagnostics, Microscan Division, West Sacramento,
California.
RECALLED BY Manufacturer, by telephone April 3, 1993, and letter April
7, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 347 boxes.
REASON When Quality control testing was performed with E. faecalis
ATCC 29212, Erythromycin demonstrated lower minimum
inhibitory concentrations (MCI's) than the expected quality
control range.
-5- _______________
PRODUCT Counter Recessed Three-Chamber Ultrasonic Cleaning System,
Model E488, used to clean debris from dental instruments.
Recall #Z-1161-4.
CODE All serial numbers beginning with 488.
MANUFACTURER Esmadent Division, Esma Chemicals, Inc., South Holland,
Illinois.
RECALLED BY Manufacturer, by undated letter sent in October 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 144 units were distributed.
REASON Device appears to have component parts that are not properly
grounded in the original factory configuration, which can
result in electric shock and/or fire.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
=====================
_______________
PRODUCT Microdase Disk - Modified Oxidase Test for Differentiation
of Micrococci from Staphylococci. Recall #Z-1111-4.
CODE Lot #4711 EXP 5/31/94.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone December 15, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nebraska, Missouri, Kansas, Oklahoma, New York, Georgia,
Oregon, Kentucky, Puerto Rico, Canada, Japan.
QUANTITY 46 vials were distributed.
REASON The device should have been made of ashless paper and was
not. Ashless paper carries less risk of interference with
the test.
_______________
PRODUCT Bacti-Disks, In Vitro Diagnostic, Microbiology Quality
Control Organisms, which are stabilized, lyophilized,
cultures of bacteria in solid disk form:
(a) Catalog #19-280; (b) Catalog #19-177; (c) Catalog # 19-
052; (d) Catalog #19-060; (e) Catalog #19-035.
Recall #Z-1112/1116-4.
CODE Lot numbers: (a) 3330; (b) 2021; (c) 2340; (d) 3730; (e)
4240.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone (a) January 18, 1993; (b) January
31, 1994; (c) November 30, 1992; (d) November 3, 1992; (e)
November 16, 1992. Firm-initiated recall complete
DISTRIBUTION (a) California, Pennsylvania, Ohio, New York, Florida, West
Virginia; (b) Florida, New Jersey, New York, Michigan,
Maryland, Wisconsin, Texas, Pennsylvania, South Carolina,
Massachusetts; (c) Pennsylvania, California, New York,
Florida; (d) Nationwide and Canada; (e) New Jersey,
Massachusetts, North Carolina, Virginia, California,
Australia.
QUANTITY Firm estimates none remains on the market.
-6- REASON Some devices were contaminated and did not exhibit normal
growth characteristics while other devices were mislabeled.
_______________
PRODUCT C.A.T. Reagent Kit, in-vitro diagnostic reagent test for
Chloramphenicol Acetyl-transferase. Recall #Z-1117-4.
CODE Lot #2141 EXP 2/28/94.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone December 29, 1993, and by fax
December 30, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Australia, Canada.
QUANTITY 72 units were distributed between 4/23/93 and 12/29/93.
REASON The control disk does not give the correct color reaction.
_______________
PRODUCT P.R.A.S. Anaerobic Transport Medium: (a) Anaerobic
Transport Medium, used in the transportation of specimens
containing anaerobic bacteria, Catalog #05-004 and 05-005;
(b) Peptone Yeast (PY) Media with Lactose, used in the study
of anaerobic bacteria, Catalog #05-105; (c) Peptone Yeast
(PY) Media with Mannitol, used in the study of anaerobic
bacteria, Catalog #05-109. Recall #Z-1118/1120-4.
CODE Lot numbers: (a) All lots; (b) 2141; (c) 2231.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone (a) January 13, 1994; (b) January
6, 1994; (c) January 4, 1994. Firm-initiated recall
complete.
DISTRIBUTION (a) California, Virginia, Missouri, Georgia, Michigan,
Colorado; (b) Massachusetts; (c) Pennsylvania.
QUANTITY Firm estimates none remains on the market.
REASON The proper color change did not occur when the media was
exposed to air.
_______________
PRODUCT (a) Thioglycollate Medium, w/o Indicator w/o Dextrose, 9 ml,
used for the cultivation of aerobic and anaerobic bacteria,
Catalog #06-4716; (b) Phenol Red Broth w/1% Melibiose, 5 ml,
used in the determination of fermentation reactions of
microorganisms, Catalog #06-2362; (c) PYR Broth 0.5 ml, used
in the rapid, presumptive identification of Group A
Streptococci, and Enterococci, Catalog #06-2085. Recall #Z-
1128/1130-4.
CODE Lot numbers: (a) 1031 EXP 12/31/93; (b) 4650 EXP 11/30/93;
(c) 4230 EXP 10/31/93.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, (a) Product was discarded on or about May 18,
1993; (b) by telephone. Product was discarded on or about
April 9, 1993; (c) by telephone January 12, 1993. Product
was discarded on or about January 2, 1993. Firm-initiated
recall complete.
DISTRIBUTION (a) Rhode Island; (b) Oklahoma, Washington D.C.; (c)
Virginia, Colorado, Georgia, California, Nevada.
-7- QUANTITY (a) 400 tubes; (b) 60 tubes; (c) 340 tubes were distributed.
Firm estimates none remains on the market.
REASON Thioglycollate Medium did not contain indicator, Phenol Red
Broth was contaminated, and Pyr broth did not show a
positive reaction.
_______________
PRODUCT (a) Lap Disks, used for the detection of leucine
aminopeptidase activity in streptococci and related genera,
Catalog #21-129; (b) Bio-Ornithine Disk, used to biotype
Haemophilus influenze and Haemophilus parinfluenzae, Catalog
#21-024; (c) Pyr/Esculin Disk, used for rapid presumptive
identification of Group A Streptococci and Enterococci,
Catalog #21-138. Recall #Z-1131/1133-4.
CODE Lot numbers: (a) 3531 EXP 8/31/94; (b) 3131 EXP 2/28/95;
(c) 0521 EXP 8/31/94.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, (a) by telephone December 10, 1993. Product
was discarded on December 8, 1993; (b) by telephone December
15, 1993. Product was discarded on December 15, 1993; (c)
by telephone May 12, 1993. Product was discarded on or
about May 4, 1993. Firm-initiated recall complete.
DISTRIBUTION (a) Arizona, New Jersey, Florida, Missouri, Kansas, North
Carolina, Texas, California, Washington, D.C., Canada; (b)
Wisconsin, Pennsylvania; (c) Nationwide, Australia, New
Zealand.
QUANTITY (a) 35 vials; (b) 3 vials; (c) 176 vials were distributed.
REASON Known positive organisms failed to react or reacted in an
atypical manner.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
==========
_______________
PRODUCT Lewis Nursery Crumbles with CSP-250, medicated swine feed,
50 pounds. Recall #V-056-4.
CODE Manufacturing dates: 2/1/94, 3/4/94, 3/30/94, 5/2/94,
5/17/94.
MANUFACTURER MFA Feed Mill, Kirksville, Missouri.
RECALLED BY MFA Inc., Columbia, Missouri, by visit May 18, 1994. Firm-
initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 18 tons.
REASON Product misformulated to contain only 50% of the drug
ingredients.
_______________
PRODUCT Orbenin-DC 7.5 G Syringe (Benzathine Cloxacillin) for
intramammary infusion in cows. Recall #V-057-4.
CODE TC5833 EXP 3/95, TC5834 EXP 3/95, TC5847 EXP 3/95, TC5848
EXP 3/95.
MANUFACTURER Smithkline Beecham, Piscataway, New Jersey.
RECALLED BY Manufacturer, by letter April 11, 1994. Firm-initiated
recall complete.
-8- DISTRIBUTION Nationwide.
QUANTITY 27,552 units of lot TC5833, 30,744 units of lot TC5834,
32,004 units of lot TC5847, 28,152 units of lot TC5848 were
distributed.
REASON Four lots of the product are subpotent.
-9-
END OF ENFORCEMENT REPORT FOR JULY 27, 1994. BLANK PAGES MAY FOLLOW.
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