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
02/05/1992
Recalls and Field Corrections: February 5, 1992
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.
Product: Matjas Herring, packed in unlabeled white, brown, and blue
plastic buckets, each weighing 22 pounds. Recall #F-114-2.
Code: None.
Manufacturer: Megfish B.V., Ijmulden, Netherlands.
Recalled by: Deli Herring, Inc., Brooklyn, New York, by telephone
May 10 and 19, 1991. Firm-initiated recall complete.
-1-
Distribution: New York, Canada.
Quantity: 2,094 buckets were distributed.
Reason: Product contains unapproved food color cochineal
Red 4A (Ponceau 4R).
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Dairy Blend DB-35, in 50 pound bags. Recall #F-111-2.
Code: All lots.
Manufacturer: Waseca Foods/Storage, Waseca, Minnesota.
Recalled by: Nesco Dairy Products Corporation, White Plains, New York.
by visit June 20, 1991. Firm-initiated recall ongoing.
Distribution: New York, New Jersey, Massachusetts, Connecticut.
Quantity: Approximately 17,200 bags were distributed.
Reason: Product is not nonfat dry milk but was deliberately
mislabeled as Dairgold or Waseca nonfat dry milk.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: OTC analgesic powder products:
(a) BC Powder, aspirin 650 mg, salicylamide 195 mg,
and caffeine 32 mg;
(b) Arthritis Strength BC Powder, aspirin 742 mg,
salicylamide 222 mg, and caffeine 36 mg.
Recall #D-199/200-2.
Code: Lot #10314 EXP 11/96.
Manufacturer: Block Drug Company, Inc., Memphis, Tennessee.
Recalled by: Block Drug Company, Inc., Jersey City, New Jersey, by
letter December 19-20, 1991. Firm-initiated recall ongoing.
Distribution: Alabama, Arkansas, Georgia, Illinois, Louisiana,
Mississippi, North Carolina, Ohio, South Carolina,
Tennessee.
Quantity: (a) 525 dozen boxes of 24; (b) 129 dozen boxes of 24
were distributed.
Reason: Possible presence of metal particles.
----
-2-
Product: Oral Pediatric Liquid Acetaminophen, in 4 ounce
containers under the following labels:
Mason Distributors, Hy Top Products, Parade, Schein,
Hudson Medical, Hi-Tech. Recall #D-203-2.
Code: All lots.
Manufacturer: Hi Tech Pharmacal Company, Inc., Amityville, New York.
Recalled by: Manufacturer, by telephone during the week of December
23, 1991, followed by letter January 15, 1992.
Firm-initiated field correction ongoing.
Distribution: Florida, Illinois, New York, Texas.
Quantity: 400 cases (24 bottles per case) were distributed.
Reason: Markings on dosage cup not totally compatible with
label dosage instructions.
----
Product: (a) Bayer Children's Chewable Aspirin Tablets containing
81 mg each, an OTC product marketed in 36 tablet bottles;
(b) Maximum Bayer Aspirin Tablets containing 500 mg each,
an OTC product in 60 and 100 tablet bottles;
(c) Genuine Bayer Aspirin Tablets containing 325 mg each,
an OTC product in 24, 100, 300, 50 tablets with 10 free
and 50 tablets with 10 free;
(d) Genuine Bayer Aspirin, an OTC product in 100 caplet
bottles. Recall #D-204/207-2.
Code: Lot numbers: (a) 1K319(S); (b) 1K636(S); (c) 1K876(S),
1K870(S), 1L878(S), 1K868(S), 1K867(S), 1K869(S),
1K870(S), 1K866(S), 1K869(S); (d) 1L884(S), 1K861(S).
Manufacturer: Sterling Drug, New York, New York.
Recalled by: Manufacturer, by telephone and by letters beginning
December 8, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 434,628 bottles were distributed; firm estimated 11,330
bottles remained on market at time of recall initiation.
Reason: Possible presence of metal particles.
----
Product: The Medicine Shoppe brand Medi-Phedrine Plus Tablets, a
nasal decongestant with antihistamine containing
60 mg Pseudoephedrine and 4 mg Chlorpheniramine Maleate,
packaged in blister packs, 24 tablets per box.
Recall #D-209-2.
Code: Lot numbers: 1A23C EXP 10/93, 1B68C EXP 11/93,
1E06C EXP 11/93, 1E51C EXP 1/94, 1F65C EXP 6/94,
1G09K EXP 7/94, 1H83C EXP 7/94.
Manufacturer: The Perrigo Company, Allegan, Michigan.
Recalled by: Manufacturer, by letter January 8, 1992. Firm-initiated
recall ongoing.
Distribution: Nationwide.
-3-
Quantity: 5,088 cartons were distributed.
Reason: Front panel of cartons incorrectly states 30 mg each.
The rear panel ingredient statement and blister pack
labeling are correct.
----
Class III -
Product: Lactulose Syrup USP, in 15 ml cups, 10 cups per tray,
10 trays per case, a Rx oral laxative for the treatment
of constipation. Recall #D-201-2.
Code: Lot #102023 EXP 4/92.
Manufacturer: Inalco SPA, Milano, Italy for Barre-National, Inc.,
Baltimore, Maryland.
Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by
letter December 31, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 287 cases were distributed; firm estimates 15 cases
remain on the market.
Reason: Particulate matter.
----
Product: Benztropine Mesylate Tablets, 0.5 mg, packaged in
strips of 10 tablets, 10 strips per box, a Rx oral
anticholinergic/antihistaminic used in the treatment
of parkinsonism. Recall #D-202-2.
Code: Lot numbers: 1H627, 1I712, 1I733.
Manufacturer: Sidmak Laboratories, Inc., East Hanover, New Jersey.
Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by letter
January 7, 1992. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 4,199 unit dose cartons were distributed; firm estimates
1,400 cartons remain on the market.
Reason: Product does not meet USP specifications for content
uniformity.
----
Product: Floxin (Ofloxacin), 400 mg, a Rx broad-spectrum antibacterial
agent for oral administration, packaged 10 tablets per
blister strip, 10 blister strips per shelf carton.
Recall #D-208-2.
Code: Lot #91M001 EXP 11/92, Bulk lot #FM2899.
Manufacturer: McNeil Laboratories, Spring House, Pennsylvania.
Recalled by: Ortho Pharmaceutical Corporation, Raritan, New Jersey,
by letter October 10, 1991. Firm-initiated recall
ongoing.
Distribution: Nationwide.
Quantity: 468,800 tablets were distributed.
Reason: Packaging error - Some blister strips contained nine
400 mg tablets and one 300 mg tablet.
----
-4-
Product: (a) Red Blood Cells; (b) Platelets; (c) Platelets,
Pheresis. Recall #B-116/118-2.
Code: Unit numbers: (a) 12F49071, 12FV32043, 12FV32049, 12J77629,
12S84579;
(b) 12F49053, 12F49066, 12F49070, 12F49078, 12F49080,
12FF57592, 12FP72209, 12FP72211, 12FP72216, 12FP72223,
12FP72224, 12J77582, 12J77583, 12J77585, 12J77586,
12J77587, 12J77590, 12J77593, 12J77594, 12J77595, 12J77599,
12J77602, 12J77604, 12J77610, 12J77611, 12J77614, 12J77615,
12J77617, 12J77618, 12J77619, 12J77620, 12J77623, 12J77625,
12J77627, 12J77628, 12J77630, 12J77639, 12J77640, 12J77641,
12J77644, 12J77646, 12KN33023, 12KN33025, 12KN33026,
12KN33027, 12KN33031, 12KN33034, 12KN33035, 12KN33036,
12KN33037, 12KN33038, 12KN33042, 12KN33044, 12KN33045,
12KQ19924, 12KQ19926, 12KQ19929, 12KQ19932, 12KQ19933,
12KQ19935, 12KQ19944, 12KQ19945, 12KQ19947, 12KQ19950,
12KQ19951, 12KQ19954, 12KQ19959, 12S84541, 12S84543,
12S84545, 12S84547, 12S84555, 12S84564, 12S84567, 12S84568,
12S84569, 12S84573, 12S84574, 12S84576, 12S84578, 12S84580;
(c) 12T34967, 12T34968, 12T34969, 12T34970, 12T34972,
12T34973, 12T34974, 12T34975, 12T34976, 12T34977, 12T34978,
12T34979, 12T34982, 12T34983, 12T34984, 12T34985, 12T34986,
12T34987, 12T34988, 12T34989, 12T34990, 12T34991, 12T34992,
12T34993, 12T34994, 12T34996, 12KT21672, 12KT21674
12KT21675.
Manufacturer: American Red Cross, Charlotte, North Carolina.
Recalled by: Manufacturer, by telephone May 29, 1991, followed by
letter May 31, 1991. Firm-initiated recall complete.
Distribution: North Carolina.
Quantity: (a) 5 units; (b) 81 units; (c) 29 units.
Reason: Blood products, incorrectly tested for the antibody
to the human immunodeficiency virus type 1 (anti-HIV-1),
were distributed.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
Product: CPI Vista T, Model 445 Multiprogrammable Pulse Generator,
single chamber pacemaker. Recall #Z-146-2.
Code: Serial numbers: 723445-723454, 723485, 723487-723489,
723505-723514, 723519, 730425.
Manufacturer: Cardiac Pacemakers, Inc., St. Paul, Minnesota.
Recalled by: Manufacturer, by letter dated November 26, 1991.
Firm-initiated recall ongoing.
Distribution: Arkansas, Massachusetts, Michigan, Oklahoma, Tennessee,
West Virginia, Brazil, Germany.
Quantity: 26 units were distributed.
-5-
Reason: Pacemakers contain a chip capacitor that is not performing
to specification. The generator may exhibit early and rapid
battery depletion with a corresponding reduction in pulse
amplitude. In addition, the potential exists for an
immediate "no output" condition upon failure of the
capacitor.
----
Class II -
Product: Class IIIb (a) Weld-bead Profiling Sensor Model WACS
BP002;
(b) Stereo seam Tracker Model WACS ST002.
Recall #Z-103/104-2.
Code: Serial numbers: (a) 2, 3, 4, 5; (b) 1, 2, 3, 4.
Manufacturer: Applied Research, Inc., Huntsville, Alabama.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan November 7, 1991. Firm-initiated field correction
ongoing.
Distribution: Alabama, Colorado.
Quantity: 8 units.
Reason: Noncompliance with the performance standards for
light-emitting products in that: (1) the Weld-bead
Profiling Sensors lacked a remote interlock connector;
(2) none of the systems incorporated an emission indicator
which turns on sufficiently prior to emission of laser
radiation to allow appropriate action to avoid exposure;
(3) Model BP002 does not incorporate a beam attenuator;
(4) the user instructions lacked the adequate information;
(5) and the firm failed to establish and maintain required
records or to submit required reports.
----
Product: Sylvan Pediascan Transilluminator, used to non-invasively
illuminate a patients internal tissues and structures:
(a) Model 100; (b) Model 200; (c) Model 500.
Recall #Z-275/277-2.
Code: Serial numbers: (a) 1001 through 1013;
(b) 2101 through 2109; (c) 5096 through 5118 and 5121.
Manufacturer: Sylvan Corporation, North Huntingdon, Pennsylvania.
Recalled by: Manufacturer, by letter November 27, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 13 units; (b) 5 units; (c) 23 units.
Reason: The infrared filters of the device may become dislodged
and allow excessive infrared light to cause burns on the
patient.
----
-6-
Product: Medtronic (a) CapSure Silicone Steroid Eluting Models
5025, Unipolar and 5026, Bipolar, implantable, tined,
ventricular, transvenous leads;
(b) CapSure SP Silicone Steroid Eluting Models 5023M,
Unipolar and 5024M, Bipolar, implantable, tined,
ventricular, transvenous leads. Recall #Z-284/285-2.
Code: Model 5023M - LAS005573V and lower;
Model 5024M - LAT009091V and lower;
Model 5025 - RS0003337V and lower;
Model 5026 - RZ0010366V and lower.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba, Puerto Rico.
Recalled by: Medtronic, Inc., Minneapolis, Minnesota, by visit
starting after December 9, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide, Australia, Hong Kong, Japan, Latin America,
The Netherlands.
Quantity: 3,927 leads were distributed.
Reason: The leads have been labeled with an incorrect "Use Before
Date", which could result in the storage of the product
beyond the specified shelf life.
----
CORRECTION: Model CO2 Laser Machine Tool Workstation (F series),
Recall #Z-261-2, which appeared in the January 29, 1992
Enforcement Report should read:
Code: Model #ML1212HB1-3016F: Serial numbers --
1112HB1081, 1112HB1083, 1112HB1088, 1112HB1082, 1112HB1084,
1112HB1094, 1112HB1093, 1112HB1096;
Model #ML2512HB2-3016F: Serial numbers -- 6025HB2497,
1125HB2209, 6025HB2203, 1112HB1086.
Manufacturer: Mitsubishi Electric Corporation,
Nagoya, Japan.
Recalled by: MC Machinery Systems, Inc., Division of
Mitsubishi International Corporation, Wood Dale, Illinois.
----
Class III -
Product: Fisher brand, 50 ml Class A Serialized Graduated Cylinder,
Catalog #08557C, for use in analysis/testing of medical
and diagnostic products. Recall #Z-282-2.
Code: Serial numbers: 230 through 239, 250 through 259,
260 through 266, 270 through 283, 290 through 349,
1190 through 1191, 1414 through 1499; 1530 through 1531.
Manufacturer: Pfeiffer Glass Division, Fisher Scientific Company, Inc.,
Rochester, New York.
Recalled by: Fisher Scientific Company, Inc., Pittsburgh, Pennsylvania,
by letter October 31, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 44 cylinders were distributed.
-7-
Reason: The cylinders were calibrated for 50 ml top level and
5 ml bottom level, while the markings show 50 ml
top level and 10 ml bottom level.
----
Product: Calibration Gas Cylinder labeled 5% CO2, 20% 02, bal.
N2 size H, for use in blood gas autoanalyzer.
Recall #Z-283-2.
Code: Lot #162051 EXP 7/94.
Manufacturer: Scott Medical Products, Plumsteadville, Pennsylvania.
Recalled by: Manufacturer, by telephone December 16, 1991. Firm-initiated
recall complete.
Distribution: Connecticut.
Quantity: 1 cylinder was distributed and is no longer in commerce.
Reason: Product actually contains 5% C02, 12% 02 and bal. N2.
----
Product: HEPCON HMS Coagulation and Associated Cartridges and
controls, a microprocessor based multichannel clot timing
instrument with automated syringe handling for pipetting
blood into single use cartridges. Recall #Z-294-2.
Code: Serial numbers 7000015 - 7000201.
Manufacturer: Medtronic HemoTec, Inc., Englewood, Colorado.
Recalled by: Manufacturer, by telephone to sales specialists October 25
and 28, 1991, followed by letter to customers dated November
5, 1991. Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: 186 instruments were distributed.
Reason: Software error - Under certain conditions the channel
label on the printout tape will indicate Channel 4 when
it should read Channel 5 or 6. The information displayed on
the monitor is correct.
----
Seizure Actions Filed:
Product: Oxygen, USP (92-642-377).
Charge: Adulterated - The methods used in, or the facilities or
controls used for, the manufacture, processing, packing,
or holding do not conform to or are not operated or
administered in conformity with current good manufacturing
practice regulations.
Firm: Dayton Medical, Inc., Dayton, Ohio.
Filed: December 26, 1991 - U.S. District Court for the
Southern District of Ohio, Western Division;
Civil #C391493, FDC #66328.
Seized: January 7, 1992; goods valued at $58,985.
----
-8-
Product: Baked goods, sugar, flour, canned goods (92-661-248).
Charge: Adulterated - Products were prepared, packed, or
held under insanitary conditions whereby they may
have become contaminated with filth.
Firm: Walsh's Doughnuts, Inc., trading and doing business
as Holiday Bakers of America, Cicero, Illinois.
Filed: January 22, 1992 - U.S. District Court for the Northern
District of Illinois; Civil #92 C 0511, FDC #66355.
Seized: January 27, 1992; products valued at approximately
$25,000.
----
Disposition of Prosecution:
Defendant: General Welding Corporation, Westbury New York and
Mr. Harry Ruddy, former president.
Product: Medical Gas Cylinders (87-521-677).
Charge: Adulterating medical gas cylinders by substituting
carbon dioxide for oxygen.
Disposition: On July 30, 1991, General Welding Corporation
and its former president, Harry Ruddy, pled guilty
to one count of adulterating medical gas cylinders.
On January 21, 1991, General Welding and Mr. Ruddy
were sentenced. Fines of $100,000 were imposed on both
the corporation and Mr. Ruddy. Mr. Ruddy was also
sentenced to three years probation, during which he
was ordered to perform 300 hours of community service.
The first six months of probation will be electronically
monitored. U.S. District Court for the Eastern District
of New York; Criminal #CR91-502, FDC #65304.
-9-