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
09/14/1994
Recalls and Field Corrections: Foods -- Class I -- 09/14/1994
September 14, 1994 94-37
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
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PRODUCT C. Ochoa Mexican Style Soft White Cheese in 8 and 12 ounce
plastic packages. Recall #F-825-4.
CODE All lots distributed prior to May 20, 1994.
MANUFACTURER C. Ochoa Cheese, Brownsville, Texas.
RECALLED BY Manufacturer, by visit May 20-21, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY Firm estimates none remains on the market.
REASON Product was contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
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PRODUCT Procainamide Hydrochloride Extended-release Tablets, USP,
500 mg, 100 tablet, 500 tablet and 1,000 tablet bottles, Rx
drug used for the treatment of ventricular arrhythmias.
Recall #D-379-4.
CODE (a) (Schein label; 100 tablets), Lot #s: 43537D, 43679D,
43681D, 43682D, 43683D, 43687D, 43752D, 43936D, 43937D,
44210D, 44211D; (b) (Schein label; 500 tablet bottles) Lot
#s: 43753D, 43934D; (c) (Danbury label; 1000 tablet bottles)
Lot #s: 43757D, 43758D.
MANUFACTURER Danbury Pharmacal Inc., Danbury, Connecticut.
RECALLED BY Danbury Pharmacal Inc., Brewster, New York by letter August
5, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 26,850 bottles were distributed. Firm estimates that
approximately 10% of the product remains on market.
REASON Product does not meet dissolution specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
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PRODUCT Cardilate Tablets (Generic name of Erythrityl Tetranitrate)
10 mg bottles of 100 tablets, used for prophylaxis and long-
term treatment of patients with frequent or recurrent
anginal pain and reduced exercise tolerance associated with
angina pectoris. Recall #D-380-4.
CODE All lots. Expiration date of April 1995.
MANUFACTURER Burroughs Wellcome Company, Greenville, North Carolina.
RECALLED BY Burroughs Wellcome Company, Research Triangle Park, North
Carolina by letter June 6, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 54,000 bottles were distributed.
REASON Potential for subpotency prior to expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
====================
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PRODUCT Cryoprecipitated AHF. Recall #B-458-4.
CODE Unit number 17033-8313.
MANUFACTURER Blood Systems, Inc., doing business as United Blood
Services, McAllen, Texas.
RECALLED BY Manufacturer by telephone December 3, 1993 with follow-up
letter dated December 20, 1993. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY One unit.
REASON Blood product, processed from improperly stored plasma, was
distributed.
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PRODUCT Source Plasma. Recall #B-459-4.
CODE Unit GU6672.
MANUFACTURER Alabama Plasma, Inc., Birmingham, Alabama.
RECALLED BY Manufacturer by facsimile September 30, 1992. Firm-
initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY One unit.
REASON Blood product which tested initially reactive for the
antibody to the hepatitis C virus encoded antigen (anti-
HCV), was distributed.
-2- RECALLS FIELD CORRECTIONS: BIOLOGICS -- CLASS III
======================
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PRODUCT Spectrogen-Trio(R) Reagent Red Blood Cells.
Recall #B-453-4.
CODE Lot #93215, EXP 6/11/93.
MANUFACTURER Organon Teknika Corporation, West Chester, Pennsylvania.
RECALLED BY Manufacturer by letters of May 5 and 6, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide, Argentina, Canada, France, Hong Kong, Ireland,
Italy, Japan, The Netherlands, United Kingdom.
QUANTITY 505 kits.
REASON Reagent Red Blood Cells which were found to be hemolyzed
were distributed.
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PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Single Donor
Plasma Liquid. Recall #B-455/457-4.
CODE Unit numbers: (a) C40308; (b) C37146 through C37149, C40332;
(c) C40332.
MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois.
RECALLED BY Manufacturer by letter June 27, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Illinois.
QUANTITY (a) 1 unit; (b) 5 units; (c) 1 unit.
REASON Blood products which were incorrectly tested for the
hepatitis B surface antigen (HBsAg); tested initially
reactive for HBsAg, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
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PRODUCT Kinemax Superstabilizer Prosthetic Knee System and
Components:
1. Catalog No. 6478-1-315, Small Tibial Baseplate;
2. Catalog No. 6478-3-315, Medium Tibial Baseplate;
3. Catalog No. 6478-5-315, Large Tibial Baseplate;
4. Catalog No. 6478-1-610, Tibial Insert W/Support Post,
Small 10mm;
5. Catalog No. 6478-3-610, Tibial Insert W/Support Post,
Medium 10mm;
6. Catalog No. 6478-5-610, Tibial Insert W/Support Post,
Large 10mm;
7. Catalog No. 6478-1-612, Tibial Insert W/Support Post,
Small 12mm;
8. Catalog No. 6478-3-612, Tibial Insert W/Support Post,
Medium 12mm;
9. Catalog No. 6478-5-612, Tibial Insert W/Support Post,
Large 12mm;
10. Catalog No. 6478-1-615, Tibial Insert W/Support Post,
Small 15mm;
-3- 11. Catalog No. 6478-3-615, Tibial Insert W/Support Post,
Medium 15mm;
12. Catalog No. 6478-5-615, Tibial Insert W/Support Post,
Large 15mm;
13. Catalog No. 6478-1-618, Tibial Insert W/Support Post,
Small 18mm;
14. Catalog No. 6478-3-618, Tibial Insert W/Support Post,
Medium 18mm;
15. Catalog No. 6478-5-618, Tibial Insert W/Support Post,
Large 18mm;
16. Catalog No. 6478-1-621, Tibial Insert W/Support Post,
Small 21mm;
17. Catalog No. 6478-3-621, Tibial Insert W/Support Post,
Medium 21mm;
18. Catalog No. 6478-5-621, Tibial Insert W/Support Post,
Large 21mm;
19. Catalog No. 6478-1-625, Tibial Insert W/Support Post,
Small 25mm;
20. Catalog No. 6478-3-625, Tibial Insert W/Support Post,
Medium 25mm;
21. Catalog No. 6478-5-625, Tibial Insert W/Support Post,
Large 25mm;
22. Catalog No. 6478-1-010, Femoral Component Assembly,
Small Left 65mm M/L 57mm A/P;
23. Catalog No. 6478-1-110, Femoral Component Assembly,
Small Right 65mm M/L 57mm A/P;
24. Catalog No. 6478-3-010, Femoral Component Assembly,
Medium Left 70mm M/L 62mm A/P;
25. Catalog No. 6478-3-110, Femoral Component Assembly,
Medium Right 70mm M/L 62mm A/P;
26. Catalog No. 6478-5-010, Femoral Component Assembly,
Large Left 75mm M/L 66mm A/P;
27. Catalog No. 6478-5-110, Femoral Component Assembly,
Large Right 75mm M/L 66mm A/P. Recall #Z-1326/1352-4.
CODE All lots.
MANUFACTURER Howmedica Inc., Division of Pfizer Hospital Products,
Rutherford, New Jersey.
RECALLED BY Manufacturer by letter January 18, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Canada, Ireland.
QUANTITY 5,757 components were distributed. Firm estimates none
remains on market.
REASON The stabilizer post/tibial insert components of the Kinemax
Superstabilizer Prosthetic Knee System loosened or
completely disassociated from the tibial baseplate
component.
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PRODUCT Modular Shoulder Humeral Cutting Block, used in orthopedic
surgery. Recall #Z-1353-4.
CODE Lot number 2698-02, Catalog No. 9945-00-101.
MANUFACTURER Kirschner Medical Corporation, Fair Lawn, New Jersey.
-4- RECALLED BY Manufacturer, by telephone January 4, 1994, and by letter
January 12, 1994. Firm-initiated recall complete.
DISTRIBUTION Alabama, Arkansas, California, Illinois, Maryland, New
Jersey, New York, Oregon, Tennessee, Texas, Italy, France,
Japan.
QUANTITY 17 pieces distributed.
REASON The neck resection angle of the humeral cutting block was
inadvertently changed to 40 degrees on this one
manufacturing lot number.
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PRODUCT Profect brand Sterile 18" x 18" Laparotomy Sponges
and 17" x 30" Operating Room Towels used during surgical
procedures to absorb blood. Recall #Z-1364/1365-4.
CODE Lot numbers: 202375, 202442, 202376, 202445, 202377, 202447
(laparotomy sponges); Lot numbers: 202249, 202261, 202268,
202276, 202282, 202286, 202312, 202563, 202598, 202791,
203096, 203209, 203214, 203229, 203248, 203249, 203294,
203393, 203394, 203468, 203469, 203470, 203472 (operating
room towels).
MANUFACTURER Grand Medical Products, Houston, Texas.
RECALLED BY Manufacturer by letter July 27, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 225 cases/100 sponges; 670 cases/80 towels and 583 cases/72
towels were distributed.
REASON The sterility of the devices may be compromised due to
package integrity and possible lack of adequate
sterilization.
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PRODUCT Threaded Metal Post Component of Knee Prosthesis:
(a) Product numbers 1866-30/75, Posterior Stabilized Tibial
Insert with Post; (b) Product Numbers 1866-84/89, Posterior
Stabilized Tibial Stabilizing Post. Recall #Z-1366/1367-4.
CODE All lots.
MANUFACTURER Lydo Precision Products, Mountain Lakes, New Jersey.
RECALLED BY DePuy Inc., Warsaw, Indiana, by letter May 7, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 7,980 units.
REASON The threaded metal stabilizing post is of this knee
prosthesis is "backing out" of the tibial inserts.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
=====================
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PRODUCT Dade Actin Cephaloplastin Reagent, in vitro diagnostic
product intended for use in activated partial thromboplastin
times and heparin therapy monitoring. Recall #Z-1358/1362.
CODE Lot numbers: APAC-578A/B/C/D/E/F; APAC-579A/B/C/D/E/F;
Catalog numbers B4218-1, B4218-2, B4218-999, 291010, 191011.
-5- MANUFACTURER Baxter Diagnostic of Puerto Rico, Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostic Inc., Miami, Florida by letter August 4,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 12,565 packages (APAC-578); 12,680 (APAC-579) were
distributed.
REASON Product may give unusually prolonged activated partial
thromboplastin time (aPTTs) when used with Citrol
Coagulation controls in normal and heparinized patients.
______________
PRODUCT Paramax Uric Reagent, in-vitro diagnostic, used for the
measurement of uric acid in serum, plasma or urine.
Recall #Z-1370-4.
CODE Lot numbers: AURC-502 through 510, Catalog #B6106-26.
MANUFACTURER Baxter Diagnostic of Puerto Rico, Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostic, Inc., Irvine, California by letter
February 5, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada, Belgium, France, Germany, Japan, Norway,
Taiwan.
QUANTITY 34,791 packages were distributed; firm estimates none
remains on the market.
REASON The product does not meet the typical precision claim nor
the stability 90 day claim.
-6-
END OF ENFORCEMENT REPORT FOR SEPTEMBER 14, 1994. BLANK PAGES MAY
FOLLOW.
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