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
09/20/1995
ENFORCEMENT REPORT FOR 09/20/95
September 20, 1995 95-38
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
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PRODUCT Giovanni's Appetizing Food brand pate in 2-1/4 ounce cans:
(a) Trout Almondine Pate; (b) Clam Creole Pate.
Recall #F-787/788-5.
CODE Lot numbers: (a) C-892; (b) C-929 and C-489.
MANUFACTURER Giovanni's Appetizing Food Products, Inc., Richmond,
Michigan.
RECALLED BY Manufacturer, by telephone May 19, 1994, followed by letter
June 1, 1994. Firm-initiated recall complete.
DISTRIBUTION (a) Florida, Georgia, Arkansas, New Jersey, Canada;
(b) Florida and Canada;
QUANTITY (a) 29 intact plus 3 partial cases; (b) 11 cases of code c-
929 and 2 cases of code C-489 were distributed.
REASON The products were introduced into interstate commerce after
the firm's temporary emergency permit was suspended and
without the advance written approval of FDA.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
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PRODUCT Maximum Strength TheraFlu Flu and Cold Medicine for Sore
Throat, apple cinnamon flavor, packaged 6 packets per box,
24 boxes per case, OTC for pain relief, fever reducing,
nasal decongestant and antihistamine. Recall #D-245-5.
CODE Lot numbers: 25149 EXP 4/30/97, 25150 EXP 4/30/97,
25151 EXP 4/30/97, 25166 EXP 5/31/97.
MANUFACTURER Sandoz Canada, Inc., Whitby, Ontario, Canada.
RECALLED BY Sandoz Consumer Pharmaceuticals, Division of Sandoz
Pharmaceuticals Corporation, Lincoln, Nebraska, by letter
dated August 31, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 275,304 boxes were distributed to wholesale or retail
accounts; 7,910 boxes were distributed to Sandoz
representatives.
REASON Product contains Aspartame but label and labeling do not
declare amount of phenylalanine per dosage unit.
HUMAN TISSUE MANDATORY RECALLS:
==========================================
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PRODUCT Human Tissue from Cadaveric Donors, Intended for Human
Transplantation. Recall #B-532-5.
CODE Donor numbers: 010295, 021794, 022094, 031194, 031894,
032394, 042093, 050294, 050394, 050493, 050593, 050693,
051194, 052693, 052794, 061394, 061694, 062494, 062494B,
062594, 070494, 070594, 070793, 071493, 072093, 072493,
072694, 072793, 073094, 080593, 080593A, 081193, 090694,
101393, 102194, 110494, 110594, 122194, 122793.
MANUFACTURER Washington State Tissue Services, Seattle, Washington.
RECALLED BY Manufacturer, by letter on March 6, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Texas, Louisiana, California.
QUANTITY Approximately 402 pieces.
REASON Human tissue from cadaveric donors was distributed which:
lacked adequate documentation about the donor's relevant
medical history related to risk factors for, or clinical
evidence of, hepatitis, B hepatitis C, or human
immunodeficiency virus (HIV) infection; tested repeatedly
reactive for the antibody to the hepatitis C virus encoded
antigen (anti-HCV); and lacked adequate documentation
indicating that donors received less than four units of
blood, blood components, colloids, or crystalloids within
forty-eight hours prior to taking the blood sample, or
lacked an adequate algorithm to ensure that there was not
hemodilution sufficient to alter test results.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
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PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-375/376-5.
CODE Unit #47C38014.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY Manufacturer, by letters dated January 19, 1995. Firm-
initiated recall complete.
DISTRIBUTION Illinois, Iowa.
-2- QUANTITY 1 unit of each component.
REASON Blood products which tested initially reactive for antibody
to the human immunodeficiency virus type 1 (anti-HIV-1), and
were not retested in duplicate, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
========================
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PRODUCT Blood Glucose Test Strips:
1. Catalog No. 200100 Quick Check One;
2. Catalog No. 200124 Relief Plus One;
3. Catalog No. 200126 Perry 1;
4. Catalog No. 200127 Brooks 1;
5. Catalog No. 200133 Top Care;
6. Catalog No. 200136 Giant Eagle;
7. Catalog No. 200300 Quick Check 3;
8. Catalog No. 200339 Full Value;
9. Catalog No. 200340 Health Mark;
10. Catalog No. 200341 Brite Life;
11. Catalog No. 200342 Valu-Rite;
12. Catalog No. 200343 Relief Plus;
13. Catalog No. 200344 Qualitest 3;
14. Catalog No. 200345 Family Pharmacy;
15. Catalog No. 200346 Longs;
16. Catalog No. 200347 Perry;
17. Catalog No. 200348 M.K.;
18. Catalog No. 200349 Good Neighbor;
19. Catalog No. 200350 Brooks. Recall #Z-1184/1202-5.
CODE All lots beginning with 30, 31, 41, or 43.
MANUFACTURER Diagnostic Solutions, Inc., Irvine, California.
RECALLED BY Manufacturer, by letters on January 26, 1995 and June 20,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 1,000,000 units were manufactured of which
most of which were distributed.
REASON Devices may provide inaccurate test results which would give
falsely elevated reading or falsely lower readings.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
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PRODUCT Sarns Turbo Membrane Oxygenator, Catalog #9443,
Part #98-0702-0545-9. Recall #Z-888-5.
CODE Lot #W312292.
MANUFACTURER Sarns, 3M Health Care, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by letter sent May 2, 1994. Firm-initiated
recall complete.
DISTRIBUTION California, Massachusetts, Missouri, North Carolina, Texas,
Sweden, Japan.
QUANTITY 61 cases (3 units per case) were distributed.
-3- REASON There is a potential packaging defect in the final bag seal
due to a damaged heater band in the Vertrod sealer used to
seal the polymylar to polymylar pouch.
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PRODUCT Columbia Sheep Blood Agar with 5% Prepared Culture Media
Plates, Product #M1013. Recall #Z-1041-5.
CODE Lot #5572 EXP 8/31/94.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois.
RECALLED BY Manufacturer, by telephone on August 2, 1995. Firm-
initiated recall complete.
DISTRIBUTION Missouri, Wisconsin, Vermont.
QUANTITY 240 plates were distributed.
REASON Some of these media plates labeled as Columbia Sheep Blood
Agar actually contained plates of TSA with 5% Bovine with
Esculin.
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PRODUCT Rusch Sterile AGT Preformed Endotracheal Tubes: (a) Catalog
#100180xxx; (b) Catalog #100181xxx; (c) Catalog #111780xxx;
(d) Catalog #111781xxx. Recall #Z-1055/1058-5.
CODE Lot numbers: 92/35/0, 92/39/0, 92/40/0, 92/41/0, 92/45/0,
92/48/0, 92/49/0, 92/50/0, 92/52/0, 93/03/0, 92/05/0,
92/11/0, 93/12/0, 93/14/0, 93/15/0, 93/19/0, 93/20/0,
93/21/0, 93/22/0, 93/25/0, 93/28/0, 93/30/0, 93/33/0,
93/36/0, 93/37/0.
MANUFACTURER Willy Rusch AG, Kernen, Germany.
RECALLED BY Rusch, Inc., Duluth, Georgia, by letter mailed October 1994.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 10,050 tubes were distributed; firm estimates none remains
on the market.
REASON Pouch seals can weaken and cause the packages to open.
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PRODUCT Centrysystem 3 Cartridge Blood Tubing Sets:
Catalog numbers: 003109-400, 003109-410, 003110-500,
003111-500, 003112-500, 003113-500, 003114-500, 003210-500,
003212-500. Recall #Z-1077/1085-5.
CODE All sets manufactured during April 1, 1995 to June 15, 1995.
Lot numbers: 04Axxxxx, 05Axxxxx, 06Axxxxx.
MANUFACTURER Cobe Renal Care, Inc., Tijuana, Mexico.
RECALLED BY Cobe Renal Care, Inc., Lakewood, Colorado, by letter June
16, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 31,000 units.
REASON The saline administration line could have an occlusion due
to plastic molding flashing which may not be detected during
the prime or recirculation modes.
-4- _______________
PRODUCT Harmonic Scalpel 5mm (Sterile) Dissecting Hook, used with
the Laparosonic Blade System used during general and
gynecological laparoscopic surgery. Recall #Z-1168-5.
CODE Catalog #U2513085, Lot numbers: LD0417-1, LD0417-2,
LD0421-1.
MANUFACTURER UltraCision, Inc., Smithfield, Rhode Island.
RECALLED BY Manufacturer, by visit between July 27 and 31, 1995, and by
letter August 16, 1995. Firm-initiated recall complete.
DISTRIBUTION Georgia, Colorado, Massachusetts, New York, Maryland,
Kansas, New Jersey, Pennsylvania, California, Missouri.
QUANTITY 144 units were distributed.
REASON The packaging tray may be punctured compromising the
sterility of the device.
_______________
PRODUCT Star X Surgical Lasers, used in podiatric surgery.
Recall #Z-1173-5.
CODE None.
MANUFACTURER Surg/Assist, Inc., Rancho Cucamonga, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan August 25, 1995. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 30 units.
REASON Noncompliance with performance standards for laser products
in that the operator's manuals contained inadequate
calibration procedures.
_______________
PRODUCT gNomos Stereotactic System, used by neurosurgeons to
determine target coordinates for brain biopsy.
Recall# Z-1174-5.
CODE Serial numbers: 0103, 0107, 0124.
MANUFACTURER Hyperion, Inc., Miami, Florida.
RECALLED BY Nomos Corporation, Sewickley, Pennsylvania, by telephone
July 19, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Massachusetts, South Carolina.
QUANTITY 3 units were distributed.
REASON A change in the length of the rear arc bracket component can
result in missed target coordinates which could result in
removing brain tissue from an unintended area during a brain
biopsy procedure.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Philips Gryoscan Magnetic Resonance Imaging Systems:
(a) Model T5 (with VAX computer), Revision 2.2.2, Revision
2.5, and Revision 2.5.2 Software System; (b) Model T5 and
(T)ACS Revision 2.2.2 Software System.
Recall #Z-1037/1038-5.
CODE All affected units.
-5- MANUFACTURER Philips Medical Systems Nederland, Best, Netherlands.
RECALLED BY Philips Medical Systems, Shelton, Connecticut, by Field
Change Order, FCO 04778-003 (software upgrade to revision
2.2.3), and 04778-006, (software upgrade to revision 2.5.2).
Firm-initiated field correction ongoing.
DISTRIBUTION Undetermined.
QUANTITY 72 units.
REASON Software error impeded proper image analysis.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS --- CLASS II
==========
_______________
PRODUCT Farnam dewormer products:
(a) Farnam Pet Products Triple Wormer for Cats and Kittens,
manufactured for Farnam Pet Products, Phoenix, Arizona, a
dewormer in 6, 7 and 8 capsule packages;
(b) Farnam Triple Wormer for Dogs, Puppies, Cats and
Kittens, manufactured for Farnam Pet Products, Phoenix,
Arizona, a dewormer in 3, 4, 5, 6, 8, 30, 50 and 100 capsule
packages; (c) Tri-Wormer, manufactured for Performer Brand
Agri Laboratories, Ltd., St. Joseph, Missouri, a dewormer in
3, 4, 5, 6, 7, 30 and 50 capsule packages.
Recall #V-040/042-5.
CODE All lots repackaged from February 1993 through June 1995.
MANUFACTURER Agribusiness Marketers, Inc., Baton Rouge, Louisiana.
RECALLED BY Manufacturer, by letter July 18, 1995. Firm-initiated
recall complete.
DISTRIBUTION Arizona, Missouri.
QUANTITY (a) 279,099 bottles; (b) 517,520 bottles; (c) 126,588
bottles were distributed.
REASON Good manufacturing practice deficiencies in repackaging and
testing operation.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
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PRODUCT Derma 4 Ointment, topical anti-infective for use on
dogs/cats, (7.5ml, 15 ml, 30ml, and 240ml tubes),
Manufactured for SmithKline Beecham Animal Health, West
Chester, Pennsylvania (listed on labeling as responsible
firm). Recall #V-039-5.
CODE Lot No. Expiry Date Product No.
79949040 8/95 6270
81264040 9/95 6270
81672040 9/95 6271
81673040 9/95 6272
81265040 9/95 6273
84799040 10/95 6273
86019040 11/95 6273.
MANUFACTURER Animal Health Group, Pfizer, Inc., Lincoln, Nebraska.
RECALLED BY Pfizer Animal Health, North American Animal Health Division,
Pfizer, Inc., Lee's Summit, Missouri, by letter dated July
27, 1995. Firm-initiated recall ongoing.
-6- DISTRIBUTION Nationwide, Korea.
QUANTITY 150,212 units were distributed.
REASON Product tested below specifications at 86% for thiostrepton
for Lot #81264040. Acceptable levels are 90% to 125%. The
remaining lots were recalled because they were near the
lower limit for potency.
-7-
END OF ENFORCEMENT REPORT FOR SEPTEMBER 20, 1995. BLANK PAGES MAY
FOLLOW.
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