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
09/03/1991
Enforcement Report for September 4, 1991
September 4, 1991.
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: Frozen Smoked Whitefish, Recall #F-521-1.
Code: No codes.
Manufacturer Novie Iceland, Incorporated, Miami, Florida.
Recalled by: Manufacturer, by telephone July 15, 1991.
Firm-initiated recall complete.
Distribution: Florida.
Quantity: 250 pounds/23 boxes were distributed.
Reason: Product contaminated with Listeria monocytogenes.
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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.
Product: Carnation brand Albacore Solid White Tuna in Water packed
in 4 1/4 oz. cans, Recall #F-518-1.
Code: Lot numbers: 85AVA/KO9BA; 85AVA/K10BA; 85AVA/K21AA;
85IVA/L05AA; 85AVA/K21BA; 85IVA/L06BA; 85IVBA/C30BA;
85IVA/E12AA; 85IVA/L05BA; 85IVA/L07AA; 85AVA/K09BA;
85AVA/K22BA; 85AVA/K09AA; 85AVA/K22BA; 85AVA/K10AA;
85IVA/L07AA; 85AVA/K10BA; 85IVA/C17AA; 85IVA/D04AA;
85IVA/K28AA; 85IVA/L06AA; 85IVA/L07BA; 85AVA/K10BA;
85AVA/K20AA; 85AVA/K27BA; 85AVA/K22AA; 85AVA/K08BA;
85IVA/C23AA; 85IVA/C21AA; 85IVA/D25BA; 85IVA/K28BA;
85IVA/L06BA; 85IVA/L08AA; 85AVA/K20BA.
Manufacturer: Neptune Packing Inc., Mayaguez, Puerto Rico.
Recalled by: Manufacturer, by letter on or about July 15, 1991.
Firm-inititated recall ongoing.
Distribution: Ohio, Florida, Colorado.
Quantity: 6,286 cs/4.25 oz. cans were distributed.
Reason: Product has no identifying can codes.
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Product: (a) Catch of the Day Stuffed Flounder Continental 4-7.5 oz.
containers, Item No. 49062 (retail), (b) New England Style
Stuffed Flounder Continental in 16-7.5 oz. portions,
Item'No. 49520 (food service), Recall #F-519/20-1.
Code: Uncoded.
Manufacturer: Fishery Products, Inc., Danvers, Massachusetts.
Recalled by: Manufacturer, by fax to brokers on August 5, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 500-1000 cases in (food service), and
firm estimates 100 cases at (retail) level were distributed.
Reason: Product contains undeclared sulfites.
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COSMETICS
Class I
NONE
Class II -
NONE
Class III -
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Levothroid Tablets (Levothyroxine Sodium, USP) 150 mcg.
packaged in individual blister packs, 10 tablets/strip;
10 strips/carton, used for replacement or substitution
therapy for diminished or absent thyroid function.
Recall #D-617-1.
Code: Control #05390, Exp. date 8/92.
Manufacturer: Rorer Pharmaceutical Corporation, Manatti, Puerto Rico.
Recalled by: Forest Pharmaceuticals, Inc., St. Louis, Missouri by
letter July 18, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 3,011/100 carton tablets were distributed.
Reason: The lengthwise edge of the blister pack strip was cut too
close allowing the strength to appear as 50 mcg. instead of
150 mcg.
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Class III -
Product: Red Blood Cells, Recall #B-369-1
Code: Unit #'s 34M30820, 34M30821, 34M30826, 34M30827.
Manufacturer: American Red Cross, Manchester, New Hampshire.
Recalled by: American Red Cross Blood Services, Burlington, Vermont.
The consignee discovered the labeling error and
returned the units to the manufacturer on November
27, 1990. Firm-initiated recall complete.
Distribution: New Hampshire.
Quantity: 4 units were distributed.
Reason: Blood products labeled with incorrect expiration date
were distributed..
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Product: Platelets, Recall #B-376-1.
Code: Unit #Y14177, exp. date 5/19/91.
Manufacturer: Champaign County Blood Bank, Urbana, Illinois.
Recalled by: Manufacturer by telephone May 20, 1991. Firm-initiated
recall complete.
Distribution: Illinois.
Quantity: One unit was distributed.
Reason: Blood component, which tested positive for syphilis was
distributed.
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Product: Platelets, Pheresis, Recall #B-377-1.
Code: Unit #'s 17FS00530, 17FS00532, 17FS00533.
Manufacturer: American Red Cross Blood Services, St. Paul, Minnesota.
Recalled by: Manufacturer by letter May 28, 1991. Firm-initiated
recall complete.
Distribution: Minnesota.
Quantity: Three units were distributed.
Reason: Blood products, untested for syphilis were distributed.
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Product: Geneva Generics Prazosin, Hydrochloride Capsules, USP,
5 mg, packaged in bottles 100, 250, 500, and unit dose
(10x10) 100's. Product may also be labeled as "Geneva
Marsam", an Rx drug used as an antihypertension drug
in the treatment of hypertension, Recall #D-618-1.
Code: Unit dose has an 18 month expiration, whereas other packages
have 2 year dating: Lot#'s 69692, Exp. date 10/91
(unit dose expired 4/91); 71510, Exp. date 11/92 (unit dose
exp. 5/92); 72499, Exp. date 3/93 (no unit dose);
72970, Exp date 3/93 (unit dose exp 9/92)
Manufacturer: Cord Laboratories, Inc., (a subsidiary of Geneva
Pharmaceuticals, Inc.), Broomfield, Colorado.
Recalled by: Geneva Pharmaceuticals, Inc., Broomfield, Colorado by
letters August 23, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,887,000 capsules were distributed.
Reason: Product does not meet dissolution specifications.
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Product: Vaponefrin Broncholilator Racepinephrine Hydrochloride
Inhalation Solution USP, an OTC packaged in 1/4 fl. oz.
1/2 fl. oz., 1 fl. oz. bottles, Recall #D-619-1.
Code: All lots.
Manufacturer: Fisons Corporation, Rochester, New York.
Recalled by: Manufacturer by letter August 8, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, international.
Quantity: Firm estimates 900-1/2 oz., 1,800/1 fl. oz. cases remain
in distribution.
Reason: Product may not meet potency specifications through
expiration date.
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Product: Deepwater Iodides Products USP packaged in (bulk)
drums lined with plastic bags for further manufacturing,
processing and repacking; (a) Potassium Iodide in various
forms including crystal, 18 mesh, 30 mesh and fines; (b)
Tincture of Iodine USP in various forms including 2%
and 7%; (c) Strong Iodine Solution 5% USP; (d)
Iodine USP in various sizes 25 pounds and 100 pounds
(e) Sodium Iodide USP in various sizes 25 pounds,
50 pounds, 100 pounds and custom packaging,
Recall #D-620/24-1.
Code: All lots that were manufactured from March 1, 1990 to
May 31, 1991 under lot number 0060 through 1151.
Manufacturer: Deepwater Iodides Inc., Carson, California.
Recalled by: Deepwater Iodides Inc., Costa Mesa, California by
letter July 19, 1991. Firm-initiated recall complete.
Distribution: Nationwide, Canada.
Quantity: (a) 250,000 pounds; (b, c, d) 2,300 gallons; (e) 8,500 pounds
Firm estimates none remain on market.
Reason: Some product labels do not bear the statement "Caution:
For Manufacturing, Processing or Repacking".
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DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Leocor brand Percutaneous Transluminal Coronary Angioplasty
(PTCA) Balloon Catheters, Recall #Z-906/13-1:
1. PICO-ST 2.0 mm Low Profile PTCA Balloon Catheter,
Model 2807-01;
2. PICO-ST 2.5 mm Low Profile PTCA Ballon Catheter,
Model 2807-02;
3. PICO-ST 3.0 mm Low Profile PTCA Balloon Catheter,
Model 2807-03;
4. PICO-ST 3.5 mm Low Profile PTCA Balloon Catheter,
Model 2807-04;
5. CORFLO 7.5PT 2.0 mm Low Profile PTCA Balloon Catheter
Model 2809-01;
6. CORFLO 7.5PT 2.5 mm Low Profile PTCA Balloon Catheter
Model 2809-02;
7. CORFLO 7.5PT 3.0 mm Low Profile PTCA Balloon Catheter
Model 2809-03;
8. CORFLO 7.5PT 3.5 mm Low Profile PTCA Balloon Catheter
Model 2809-04.
Code: Lot numbers:
1. 316, 322, 333, 343, 349, 364.
2. 312, 317, 319, 331, 341, 346, 353, 370, 373.
3. 313, 314, 318, 329, 332, 336, 344, 354, 356, 371, 374.
4. 315, 321, 330, 334, 355, 375,
5. 326, 339, 376.
6. 327, 338, 351, 365, 377, 379.
7. 328, 337, 345, 352, 359, 366, 368, 369, 383.
8. 324, 340, 348, 357, 378, 380.
Manufacturer: Leocor, Inc., Houston, Texas.
Recalled by: Manufacturer by letter August 5, 1991. Firm-initiated
recall ongoing.
Distribution: Alabama, Florida, Arizona, Georgia, New York, Texas,
California, Austria, France, Italy.
Quantity: (1-4) 235 catheters; (5-8) 489 catheters were distributed.
Reason: Product sterility may be compromised due to defective
package seals.
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Product: Mini-Vol Extension Set, used as a low volume connective
tubing between the patient and the infusion pump in which
drugs are dispensed, Recall #Z-957-1.
Code: Lot numbers: MF90325, MF90329.
Manufacturer: Medfusion Systems, Inc., Duluth, Georgia.
Recalled by: Manufacturer by letter July 31, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 392 boxes; (b) 396 boxes were distributed.
Reason: The component tubing has an inside diameter of 0.25
rather than 0.15.
Class III -
NONE
VETERINARY PRODUCTS
NONE
Seizure Actions Filed:
Product: Manhood Plus Potent Formula (91-596-010.
Slim N Clenz (91-596-011).
Charge: The articles are drugs, which may not be introduced or
delivered for introduction into interstate commerce since
they are new drugs and no approvals of applications are
in effect for such drugs; their labeling falsely represents
and suggests that the article is safe and effective for
their intended use in the prevention or treatment of disease
conditions, which representation and suggestions are contrary
to fact; and their labeling fails to bear adequate directions
for use, and they are not exempt from such requirement under
21 CFR 201.115 since the articles are unapproved "new drugs".
Firm: Falko Distributing Company, Valparaiso, Indiana.
Filed: July 26, 1991 - U.S. District Court for the Northern District
of Indiana, Hammond Division; Civil #HR91-0258, FDC #66234.
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