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
05/12/1993
Recalls and Field Corrections: Foods -- Class II -- 05/12/1993
May 12, 1993 93-19
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________
PRODUCT Gourmet Popcorn in 12 oz and 3 lb-8 oz plastic bags.
Recall #F-313-3.
CODE Production weeks coded with colored ties:
(a) Green Tie - Production Week - 4/05/93,
(b) Yellow Tie -Production Week - 3/29/93,.
(c) Blue Tie - Production Week - 3/22/93,.
(d) Orange Tie -Production Week - 3/15/93.
MANUFACTURER Lobby Shoppes, Inc., Springfield, Ohio.
RECALLED BY Manufacturer, by telephone April 9, 1993.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 40 cases/12 oz.; 78 bags/3 lb-8 oz. were
distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Whiskey Sour Mix in 33.8 fl. oz bottles.
Recall #F-316-3.
CODE M216; M236; M251; M265; M280; M286; M293; M300;
M309; M316; M324; M334; M338; M345; M348.
MANUFACTURER Lemon-X, Westbury, New York.
RECALLED BY Manufacturer by telephone April 15, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4704 cases (12 bottles/case) manufactured between
Aug. 1992 and Dec. 1992 .
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Escolar Fish (known as oil/castor oil fish).
Recall #F-317-3.
CODE No codes.
MANUFACTURER Floribbean Wholesale, Incorporated, Margate,
Florida.
RECALLED BY Manufacturer by sales manager contacting consignees
on March 13, 1993. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 52 pounds of fish were distributed.
REASON Adulterated. Product contains excessive oil.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________
PRODUCT Nestea Plunge Iced Tea in 1 gallon plastic jugs,
Nestea Pure Iced Tea in pint and 1/2 gallon size
containers. Recall #F-311/312-3.
CODE (a) 1 gallon size jugs coded with following "sell by
dates": 1-08, 1-21, 1-26, 2-02, 2-05, 2-20, 2-28,
3-04, and 3-08; (b) 1 pint size cartons coded with
"sell by date" 2-11; and (c) 1/2 gallon containers
coded with the "sell by date" 3-01. The manufac-
turing plant number: 51-4111, is also printed
on the label of each container.
MANUFACTURER Flav-o-rich, Inc., Bristol, Virginia.
RECALLED BY Manufacturer by "Market Withdrawal" memos dated
Jan. 16, 1993 (1 gallon), Jan. 19, 1993 (pint),
and Jan. 29, 1993 (half gallon).
DISTRIBUTION Virginia, West Virginia, Tennessee, South Carolina,
Kentucky.
QUANTITY 11,683 1-gallon containers, 9,280 1-pint
containers and 874 1/2 gallon containers.
REASON Tea is contaminated with yeast and/or mold.
_______________
PRODUCT Canned mandarin oranges. Recall# F-315-3.
CODE All lots with P31 or P35 in top line can code.
MANUFACTURER Guangxi Xingan Canning Plant, Guangxi Province,
Peoples Republic of China.
RECALLED BY Mitsui Foods, Inc., Hackensack, New Jersey, by
E-Mail Dec. 24, 1992 and letters dated Feb. 19,
1993. Firm-initiated ongoing.
DISTRIBUTION Florida, Ohio, Connecticut, Vermont, Maryland,
Wisconsin, Michigan, Pennsylvania, New York,
New Jersey.
QUANTITY Approximately 4000 cases of 24 11-oz cans.
REASON Product is contained in detinning cans and is
unfit for food.
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RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________
PRODUCT Propylthiouracil Tablets 50 mg, used for treatment
of hyperthyroidism, under the following labels
and units per bottle:
Blue Cross -- 100, 1000;
Qualitest Products -- 100;
Major Pharm. Corp. -- 100, 1000;
Schein Pharm. Inc. -- 100, 1000;
Geneva Pharm. Inc. -- 100, 1000;
Rugby Lab., Inc., -- 1000;
URL -- 1000. Recall #D-247-3.
CODE All lots within expiration date.
MANUFACTURER Halsey Drug Co., Brooklyn, New York.
RECALLED BY Manufacturer, by phone Apr. 8, 1993 and letter
Apr. 12, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2 million tablets were distributed.
REASON Use of an unapproved inactive ingredient.
_______________
PRODUCT Metronidazole Tablets, 250 and 500 mg, used as oral
synthetic antiprotozoal and antibacterial, under the
following labels and units per bottle:
Blue Cross -- 250 mg: 100, 250, 500, 1000;
500 mg: 100, 250, 500, 1000;
Qualitest -- 250 mg: 100, 250, 500;
500 mg: 50, 100, 500;
IDE Star -- 250 mg: 250;
Aligen -- 250 mg: 100, 250; 500 mg: 100;
Mason -- 250 mg: 100, 500; 500 mg: 100.
Recall #D-248/249-3.
CODE All lots within expiration date.
MANUFACTURER Halsey Drug Co., Brooklyn, New York.
RECALLED BY Manufacturer, by letter Apr. 12, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Unapproved change in the ratio of two inactive
ingredients.
______________
PRODUCTS Acetaminophen and Codeine Phosphate Tablets.
300/15 mg, 300/30 mg, and 300/60 mg, in sizes of
100, 500, and 1000's, a prescription analgesic
product under the following labels: Blue Cross,
Major Pharm., Harbor Pharm., Qualitest, Par-Med,
IDE, Purepac and Schein. Recall #D-252/254-3.
CODE All codes with expiration date.
MANUFACTURER Halsey Drug Co., Brooklyn, New York.
-3-
RECALLED BY Manufacturer by letter Apr. 12, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Use of an unapproved inactive ingredient.
_______________
PRODUCT Aralen Phosphate (chloroquine phosphate) Tablets,
USP, 500 mg, 25 tablets per bottle and 500 tablets
per bottle, for use in Malaria and Extraintestinal
Amebiasis only. Recall #D-257-3.
CODE Lot numbers: SO35HB, SO22HC, SO44HB, 668FE.
MANUFACTURER Winthrop Pharmaceuticals, New York, NY.
RECALLED BY Manufacturer, by letter Apr. 15, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 83,858 bottles. Firm estimates none remains on
the market.
REASON Product does not meet dissolution specifications.
______________
PRODUCT Isoxsuprine Hydrochloride Tablets, 10 mg, 1000
tablets per bottle, for the relief of symptoms
associated with cerebral vascular insufficiency.
Recall #D-258-3.
CODE Lot No. 0E023; Exp: 6/93.
MANUFACTURER Vitarine Pharm., Inc., Springfield Gardens,
New York.
RECALLED BY Manufacturer, by letter Apr. 12, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 96 bottles were distributed.
REASON A bottle of the 10 mg strength was found mislabeled
as 20 mg.
_______________
PRODUCT Levothyroxine Sodium Tablets, USP, 0.1 mg, 0.15 mg,
0.2 mg, 0.3 mg, used as replacement or supplemental
therapy in patients with hypothyroidism.
Recall #D-259/262-3.
CODE Lots H677, H706, H707, H722, L145.
MANUFACTURER Pharmaceutical Basics, Inc., Denver, Colorado.
RECALLED BY Manufacturer, by letter April 21, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Potency not assured through expiration date.
-4-
______________
PRODUCT Swan Castor Oil, 2 fluid ounce amber plastic
bottles, 72 bottles per case. Recall #D-263-3.
CODE Lot No. 30148, Exp. 2/96.
MANUFACTURER Cumberland-Swan, Inc., Smyrna, Tennessee.
RECALLED BY Manufacturer, by phone Apr. 30, 1993, and by
letter May 3, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 440 cases (72 bottles/case) were distributed.
REASON A bottle of Aromatic Ammonia Spirits was found
mislabeled as Castor Oil.
RECALLS AND FIELD CORRECTIONS: DRUG -- CLASS III
_______________
PRODUCT Propoxyphene Napsylate & Acetaminophen Tablets,
50/325 mg, 100/650 mg, a prescription analgesic
under the following labels and units per bottle:
Blue Cross -- 100/650 mg: 100, 500, 1000;
Major Pharm. -- 50/325 mg: 500; 100/650 mg: 500;
Qualitest -- 50/325 mg: 100; 100/650 mg: 500;
Par-Med -- 50/325 mg: 100, 500; 100/650 mg:
500, 550, 1000; 100/650 mg: 100, 500, 550, 1000;
Rugby Lab -- 50/325 mg: 100; 100/650 mg: 500,
1000; 100/650 mg: 100, 500, 1000;
IDE Star -- 100/650 mg: 100, 500.
Recall #D-250/251-3.
CODE All lot within expiration date.
MANUFACTURER Halsey Drug Co, Brooklyn, New York.
RECALLED BY Manufacturer, by letter Apr. 12, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Use of unapproved firm to perform film coating.
______________
PRODUCT (a) Filibon Forte Prenatal Tablets, packaged in
bottles of 100 tablets, used as prescription
multivitamin-multimineral supplement for pregnant or
lactating women, and (b) Filibon F.A. Prenatal
Tablets packaged in bottles of 30 and 100 tablets
and of 25,000 tablets, used as prescription
multivitamin-multimineral supplement for pregnant or
lactating women. Recall #D-255/256-3.
CODE (a) Control Numbers 324-361 and 333-347;
(b) All lots.
MANUFACTURER Lederle Laboratories, Pearl River, New York.
RECALLED BY Manufacturer, by letter Mar. 31, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and International.
-5-
QUANTITY Undetermined.
REASON Potency of pyridoxine and riboflavin ingredients
not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: MEDICAL DEVICES -- CLASS II
______________
PRODUCT (a) Aortic Arch Cannula, (b) Left Heart Vent
Catheter, (c) Vent Catheter, (d) Venous Return
Catheter, (e) High Flow Aortic Arch Cannula,
(f) Two Stage Venous Return Catheters, (g) D4
Aortic Arch Cannula, (h) Intracardiac Suckers,
(i) Temperature Probe Connector, and (j) Venoatrial
Catheter, Recall #Z-449/458-3.
CODE Lot numbers: (a) M156190; (b) M153100; (c) M148940;
(d) M153050, M130750, M154050, M154030; (e) M158950,
M131560, M122260, M156100, M151340; (f) M153120,
M158550; (g) M137560, M158750, M137460, M158770;
(h) M153160, M158930, M153110, M156090; (i) M133950,
M137350; and (j) M158730.
MANUFACTURER Sarns, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by letter sent Oct. 10, 1992 and by
telephone on Oct. 13 - Oct. 15, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and International.
QUANTITY A total of 1648 cases, each containing 20 products,
were distributed. The total number of products
distributed is 32,960 units.
REASON Packaging heat seal on sterile products may fail.
______________
PRODUCT SITE Power Handpiece II, Recall #Z-459-3.
CODE Part #400-1500.
MANUFACTURER Site Microsurgical Systems, Inc., Horsham, Penn.
RECALLED BY Manufacturer, by letter Feb. 26, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international
QUANTITIY 123 units were distributed. Firm estimates that
26 units remain in commerce.
REASON Device is adulterated and misbranded in that it
lacked sufficient power to drive the SITE cutting
tips, and lacked complete information pertaining to
antoclaving as well as firm's name and address on
some of the inserts.
______________
PRODUCT Phacoemulsification Needles used in ocular surgery
for removal of cataracts, labeled as (a) 30 Degree
CD Phaco Pak and (b) 30 Degree Macrobore Plus Phaco
Pak. Recall #Z-516/517-3.
-6-
CODE Product Codes: (a) 600-2830 and (b) 600-2630 and
Lot Numbers: (a) 315464 and (b) 314216.
MANUFACTURER Site Microsurgical Systems, Inc., Horsham, Penn.
RECALLED BY Manufacturer, by phone on Feb. 19, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, Pennslyvania, Florida, Georgia,
Illinois, California, North Carolina, Texas,
Maryland, Arizona, Nevada, Kansas, Alaska,
New Mexico, Utah, Canada, France and Japan.
QUANTITY Firm estimates that all involed product had
either already been returned or was in transit
to the firm.
REASON Packs contained 45 degree Phaco Needles and were
labeled as containing 30 degree Phaco Needles.
______________
PRODUCT Prosorba Immunoadsorption Treatment Columns, for
use in therapeutic removal of immunogobin G(IgG)
and IgG. Recall #Z-518-3.
CODE All lots.
MANUFACTURER Imre Corporation, Seattle, Washington.
RECALLED BY Manufacturer, by letter on Feb. 25, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,981 units were sold from Nov. 1992 to Feb. 1993.
It is unknown how many columns remain in commerce.
REASON Contraindication not to use the columns with ACE
inhibitors and possible side effects were not
included in the accompanying literature.
_______________
PRODUCT 7mm Cannulated Drill Bits used in a total system
for arthroscopic cruciate reconstruction.
Recall #Z-519-3.
CODE Catalog #013543, Lot #392.
MANUFACTURER Acufex Microsurgical, Inc., Mansfield, Mass.
RECALLED BY Manufacturer, by phone on Jan. 27, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Italy, Taiwan and England.
QUANTITY 6 bits.
REASON 8mm Endoscopic Cannulated Drills were packaged and
mislabeled as 7mm Cannulated Drills.
_______________
PRODUCT Glass Syringes with Metal Luer Lock, labeled as
(a) 5cc Syringe, (b) 10cc Syringe and (c) 20cc
Syringe. Recall #Z-520/522-3.
CODE Lot Numbers (a) 4178-4182, 4253-4255, 4308-4310,
4330, 4334, 4633, 3929; (b) 7376, 4298; and
(c) 4444, 4371.
-7-
MANUFACTURER Tsubasa Industry Co., Ltd., Tokyo, Japan.
RECALLED BY International Steel, Plastic & Glass, Inc.,
New Milford, Connecticut by phone on July 31, 1990.
Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Hampshire, Texas, Virginia,
Georgia.
QUANTITY Approximately 125,000 syringes were distributed.
REASON Luer lock mechanism was defective which could result
in leakage.
______________
PRODUCT Cambridge 7000i Interpretive ECG System used to
acquire data from 12 leads in 3, 4, or 6 channel
formats. Recall #Z-523-3.
CODE 7008, 7016, 7036, 7037, 7038, 7039, 7040, 7041,
7042, 7043.
MANUFACTURER Healthwatch Technologies, Inc., Broomfield,
Colorado.
RECALLED BY Manufacturer, by letter on or about Apr. 2, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Texas, Oklahoma.
QUANTITY 10 units produced with the 4.0 driver software were
distributed.
REASON Software lockup occurs when both the medication and
patient's age are filled in on the history screen.
______________
PRODUCT Thermagard Nebulizer Heater used for,
Recall #Z-524/525-3.
CODE Catalog Nos. 5705 and 5705E.
MANUFACTURER Pegasus Research Corporation, Costa Mesa,
California.
RECALLED BY Manufacturer, by letter dated February 26, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Colorado, California, Indiana, Missouri,
Massachusetts, New Hampshire, New York, Texas,
Wisconsin, and international.
QUANTITY 91 units were distributed.
REASON Devices fail to heat due to a defective seal,
located on the bottem of the unit's housing, which
allows moisture to enter the housing and short
circuit the unit.
______________
PRODUCT E-Z Ject Disposable Insulin Syringes, labeled
as (a) 28G x 1/2", 1CC and (b) 28G x 1/2", 1/2CC.
Recall #Z-526/527-3.
CODE (a) Catalog No. 002-129, Lot 920109 and (b) Catalog
No. 002-130, Lot 920109.
MANUFACTURER Can-am Care Corp., West Chazy, New York.
-8-
RECALLED BY Manufacturer, by letter Mar. 9, 1993, and
Apr. 12, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 127,600 units.
REASON Syringes were sterilized with a concentration of
sterilant gas below specification.
_______________
PRODUCT Cytomegalovirus (CMV) IgG Clin-ELISA Kit used for
detecting antibodies in human serum.
Recall #Z-528-3.
CODE Product No. 4530.
MANUFACTURER Incstar Corp., Stillwater, Minnesota
RECALLED BY Manufacturer, by phone on Feb. 26, 1993 and
Mar. 1, 1993, and by letter Mar. 2 and 3, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 152 test kits were distributed from Oct. 1992 to
Jan. 1993.
REASON There is a potential for error in the kit which may
allow low positive samples to read negative.
_______________
PRODUCT MediHeat Infant Heel Warmer, Recall #Z-529-3.
CODE Catalog No. MH-9, Lot #MH9G1A.
MANUFACTURER Heatmax, Inc., Dalton, Georgia.
RECALLED BY Manufacturer. Firm-initiated recall complete.
DISTRIBUTION Southwestern region of the United States.
QUANTITY Firm estimates no product remains on the market.
REASON Device may cause burns when insufficient covering is
used between the skin and the heat pad.
_______________
UPDATE IMED Gemini Volumetric Infusion Pump and
Controller. Recall #Z-504/505-3 which appeared in
the May 5, 1993, Enforcement Report should read:
REASON: These devices are subject to pumping
mechanism failures caused by severe impacts which
may result in uncontrolled excessive fluid delivery.
RECALLS AND FIELD CORRECTIONS: MEDICAL DEVICES -- CLASS III
______________
PRODUCT Cardiomet 1000 Oxygen Sensor Membrane Kit, used
during open heart surgery as an extra means of
monitoring blood oxygen. Recall #Z-494-3.
CODE Lot CMK/1050, Expiration September 1993.
MANUFACTURER Biomedical Sensors Ltd., Bucks, England.
-9-
RECALLED BY Biomedical Sensors, Malvern, Penn. by visiting the
three product recipients, searching their
inventories, and retrieving all units found during
the inventory search. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania, Washington D.C., Georgia.
QUANTITY 11 boxes were shipped from manufacturer
to the initial distributor.
REASON The kit was labeled with an incorrect expiration
date (Sept. 93 instead of April 93).
_______________
PRODUCT Various Culture Media: (a) Enliten Standard Methods
Bacteria Broth; (b) Purple Broth with Xylose and
Durham Tube; (c) LPM Agar Plate; (d) E20A Agar;
and (e) R2A Medium Plate. Recall #Z-509/513-3.
CODE (a) Catalog #FF3471, Part #327A, Lots 252901
through 252905; (b) Product #T8029, Lot #6225;
(c) Product #M1062, Lot #7013; (d) Product #M1124
Lot #7427; and (e) Roduct #M1065, Lot #6471.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois.
RECALLED BY Manufacturer, by phone on Aug. 12, 1992.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin, Maryland.
QUANTITY 16 cartons were distributed. Firm estimates no
product remains on the market.
REASON (a) Some of the tubes were mislabeled as Part# 223A,
Enlitin Standard Methods Yeast and Mold Broth
instead of Enlitin Standard Methods Bacteria Broth;
(b) Broth tubes did not show the expected
reaction for Listeria monocytogenes, due to
incorrect pH adjustment during manufacturing;
(c) Plates failed to yield growth of Listeria
monocytogenes, due to failure of the firm to
adequately store the ingredient(s) used in the
manufacture of the device; and (d) & (e) Devices
were found to be contaminated with microorganisms.
_______________
PRODUCT Silastic RX-60 Medical Grade Tubing, Special.
Recall #Z-514-3.
CODE Lot #HH082264.
MANUFACTURER Dow Corning Corp., Hemlock, Michigan.
RECALLED BY Manufacturer, by fax on Dec. 2, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Texas.
QUANTITY 5000 tubes were distributed.
REASON Tubing is subject to crazing, due to improper
curing.
-10-
______________
PRODUCT Deknatel Teflon Pledget used for suture support in
cardiovascular surgery to protect the cardiovascular
tissue from suture tearing. Recall #Z-515-3.
CODE Catalog #K-705, Lot #02656.
MANUFACTURER Deknatel, Inc., Fall River, Mass.
RECALLED BY Manufacturer, by phone on May 27, 1992, and letter
of June 19, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 540 pieces.
REASON Some of the outer shelf boxes for Catalog #L-705,
Lot #02656 were incorrectly labeled as Catalog
#K-705, Lot #02656.
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END OF ENFORCEMENT REPORT FOR MAY 12, 1993. BLANK PAGES MAY
FOLLOW.
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