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.
December 15, 1999 99-50
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________
PRODUCT
a) Hot-Smoked Uneviscerated Round Scad, in 6 ounce plastic
packages; b) Air-Dried Herring, in 6 ounce packages.
Recall #F-056/057-0.
CODE
None.
MANUFACTURER
Fil-Fish Manufacturing Company, Fullerton, California.
RECALLED BY
Manufacturer, by letter faxed on March 13, 1999, followed by
telephone from March 13 to 16, 1999, and by press release on
March 30, 1999. Firm-initiated recall complete.
DISTRIBUTION
Illinois, California, New Jersey.
QUANTITY
a) 15 cases (40 packages per case); b) 21 cases (40 packages per
case) were distributed.
REASON
Products, uneviscerated fish, have the potential to support the
growth of and toxin production by Clostridium botulinum.
_______
PRODUCT
Cheeses Blintzes:
1. Frozen Cheese Blintzes
a) Packaged in a yellow paper container with brown
lettering, labeled in part, "*** Ratner's *** RESTAURANT *** 6
CHEESE *** BLINTZES *** NET WT 13 OZS. (369g) *** MANUFACTURED
BY: RATNER'S RETAIL FOODS, INC. *** NEW YORK, N.Y. 10002 ***".
The product is marked with UPC 78364 10001.
b) packaged in an orange and white paper container,
labeled in part, "*** Ratner's *** RESTAURANT *** All Natural
*** 12 Cheese *** Blintzes *** NET WT. 26 OZ. (1 LB. 10 OZ.) 728g
*** MANUFACTURED BY RATNER'S RETAIL FOODS, INC., NEW YORK, N.Y.
10002 ***". The product is marked with UPC 78364 00104.
2. Frozen Jumbo Cheese Blintzes, packaged in a yellow paper
container with blue lettering, labeled in part, "*** Ratner's
***RESTAURANT *** 6 JUMBO *** CHEESE *** BLINTZES *** NET WT. 1
LB. 4 OZS. (567g) *** Manufactured by Ratner's Retail Foods, Inc.
New York, N.Y. 10002 ***". The product is marked with UPC 78364
00031.
3. Frozen Blueberry Cheese Blintzes, packaged in a blue
paper container with yellow lettering, labeled in part,
"***Ratner's *** RESTAURANT *** 6 BLUEBERRY *** CHEESE ***
BLINTZES *** NET WT. 13 OZS. (369g) *** MANUFACTURED BY: RATNER'S
RETAIL FOODS, INC. *** NEW YORK, N.Y. 10002 ***". The product is
marked with UPC 78364 00033.
Recall #F-058/060-0.
CODE
None. All product on the market at the time of the recall is
affected.
MANUFACTURER
Ratner’s Retail Foods, Inc., New York, New York.
RECALLED BY
Manufacturer, by letter on September 14, 1999. Completed recall
resulted from sample analysis by the New York City Department of
Health and the New York State Department of Agriculture and
Markets.
DISTRIBUTION
New York, New Jersey, Florida, Maryland, California, Connecticut,
Colorado, Massachusetts, Minnesota, Wisconsin.
QUANTITY
Approximately 125,000 individual packages were distributed in the
last 6 months.
REASON
Products may be contaminated with Salmonella.
________
PRODUCT
Hansung Salted Yellow Croaker, vacuum packed uneviscerated fish,
in 16 ounce multi-colored packages. Recall #F-061-0.
CODE
None.
MANUFACTURER
Sung Fish Company Ltd., Vancouver, British Columbia, Canada.
RECALLED BY
Pacific Giant, Inc., Los Angeles, California, by letter faxed on
January 19, 1999, and by mail on January 20, 1999. Firm-
initiated recall complete. See also FDA press release P99-2,
January 21, 1999.
DISTRIBUTION
Arizona, California, District of Columbia, Hawaii, Illinois, New
York, Texas, Washington state.
QUANTITY
Approximately 800 cases (30 packages per case) were distributed.
REASON
Product, uneviscerated fish, has the potential to support the
growth of and toxin production by Clostridium botulinum.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Assorted Sugar Stick Candy, packed in 4 ounce retail plastic
bags, under the Papas label.
Recall #F-063-0.
CODE
All bags distributed on or before 7/23/99.
MANUFACTURER
Chris A. Papas & Son Company, Inc., Covington, Kentucky.
RECALLED BY
Manufacturer, by telephone or visit on or about August 1, 1999.
Firm-initiated field correction (relabeling) complete.
DISTRIBUTION
Ohio and Kentucky.
QUANTITY
Approximately 5 cases (240bags per case) were distributed.
REASON
Product contains undeclared FD&C Yellow No. 6, FD&C Red No. 40,
FD&C Red No. 3, and FD&C Blue No. 1.
________
PRODUCT
Dominick's brand Apple Juice in 48 ounce glass jars.
Recall #F-064-0.
CODE
"914061-01" on the lid; UPC code "3828103021".
MANUFACTURER
Mason County Fruit Packers Co-op, Inc., Ludington, Michigan.
RECALLED BY
Manufacturer, by press release issued April 9, 1999, and by E-
mail April 8 and 12, 1999. Firm-initiated recall complete.
DISTRIBUTION
Illinois and Indiana.
QUANTITY
291 cases (6 bottles per case) were distributed.
REASON
Product may contain pieces of glass.
________
PRODUCT
a) Ike's Smoked Salmon Alder Smoked; b) Ike's Salmon Dip. Net
weight for both products is 8-12 ounces.
Recall #F-068/069-0.
CODE
a) 10 JAN 00; b) 25 DEC 99.
MANUFACTURER
Ike's Fish, Poulsbo, Washington.
RECALLED BY
Manufacturer, by visit on November 25, 1999, followed by letter.
Firm-initiated recall complete.
DISTRIBUTION
Washington state.
QUANTITY
a) Approximately 50 pounds; b) Approximately 20 pounds were
distributed.
REASON
Products contained undeclared wheat.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________
PRODUCT
Di-Tab Unmilled Dicalcium Phosphate Dihydrate, Calcium Phosphate
Dibasic, USP Grade-F.C.C. Grade for manufacturing use only, used
to manufacture tableted calcium containing dietary supplements.
Recall #F-062-0.
CODE
Lot Numbers 7275 and 7276.
MANUFACTURER
Rhodia, Inc., Chicago Heights, Illinois.
RECALLED BY
Rhodia, Inc., Cranbury, New Jersey, by telephone and E-mail on
November 12, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
California, Canada, Indonesia.
QUANTITY
2,240 25-kg bags were distributed; firm estimated that 35 percent
of the product remained on market at time of recall initiation.
REASON
Product may contain pieces of rubber gasket material and plastic.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
________
PRODUCT
Warrick Pharmaceuticals brand Albuterol, USP Inhalation Aerosol,
17 g, 200 metered inhalations, Rx indicated for the prevention
and relief of bronchospasm in patients with reversible
obstructive airway disease, and for the prevention of exercise-
induced bronchospasm.
Recall #D-058-0.
CODE
NDC #59930-1560-1; Batch #9-BBS-525 EXP 8/01.
MANUFACTURER
Schering Laboratories, Inc., Kenilworth, New Jersey.
RECALLED BY
Manufacturer, by letters dated August 28, 1999, and September 15,
1999. Firm-initiated recall complete.
DISTRIBUTION
Alabama, Connecticut, Florida, Georgia, Kentucky, Maryland,
Massachusetts, New Jersey, New York, North Carolina, Ohio,
Pennsylvania, Rhode Island, Tennessee, Virginia, West Virginia.
QUANTITY
190,679 units were distributed; firm estimates none remains on
the market.
REASON
Some units fail to contain active ingredient.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________
PRODUCT
Rugby Hemorrhoid Preparation Suppositories in cardboard box
containing 12 suppositories, OTC, used to temporarily shrink
hemorrhoidal tissue and relieve the itching, burning and
discomfort associated with hemorrhoids.
Recall #D-113-0.
CODE
Lot #906226.
MANUFACTURER
Hi-Tech Pharmacal, Inc., Amityville, New York.
RECALLED BY
Rugby Laboratories, Norcross, Georgia, by letter on August 26,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Georgia, Indiana, Kentucky, Michigan, North Carolina, New Jersey,
Ohio, Oregon, Pennsylvania, Texas.
QUANTITY
1,182 boxes were distributed; firm estimated that 250 boxes
remained on market at time of recall initiation.
REASON
Labeling - Product lacks pregnancy-nursing warning.
________
PRODUCT
Various Human Drugs:
1. Ascorbic Acid Injection, 222 mg/mL, 30 mL vial, 4 lots
NDC #30727-645-80 for MERIT PHARMACEUTICALS
2. Ascorbic Acid Injection, 500 mg/mL, 50 mL vial, 4 lots
NDC #0402-1083-50 for STERIS LABS label
NDC #49072-039-50 for McGUFF COMPANY label
NDC #11694-206-50 for KEY label
3. Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL
vial, NDC #0402-0191-30 for STERIS LABS label
NDC #0364-6559-56 for SCHEIN PHARMACEUTICAL
NDC #0839-5628-36 for MOORE MEDICAL label
NDC #0536-2501-75 for RUGBY LABORATORIES label
4. Bacteriostatic Water for Injection, USP, 30 mL vial, NDC
#0402-1057-30 for STERIS LABS label
NDC #66467-2611-3 for DARBY GROUP label
NDC #0839-5180-36 for MOORE MEDICAL label
NDC #0536-2620-75 for RUGBY LABORATORIES label
5. Chorionic Gonadotropin for Injection, USP, 5,000 USP units,
Lyophilized With Diluent, 10 mL vial set,
NDC #0402-0125-10 for STERIS LABS label
NDC #57548-125-10 for EVEREADY label
NDC #44087-8005-3 for SERONO LABORATORIES label
6. Chorionic Gonadotropin for Injection, USP, 10,000 USP
units, Lyophilized With Diluent, 10 mL vial set,
NDC #0402-0126-10 for STERIS LABS label
NDC #0364-6706-54 for SCHEIN PHARMACEUTICAL label
NDC #44087-8010-3 for SERONO LABORATORIES label
NDC #0182-1165-63 for ZENITH-GOLDLINE LABORATORIES label
NDC #99012-126-10 for R. W. ENTERPRISES label
7. Edetate Disodium Injection, USP, 3g/20 mL (150 mg/mL), 20 mL
vial, NDC #0402-0277-20 for STERIS LABS label
NDC #0364-2485-55 for SCHEIN PHARMACEUTICAL label
NDC #49072-177-20 for McGUFF COMPANY label
NDC #0456-0724-17 for FOREST PHARMACEUTICAL label
NDC #30727-318-65 for MERIT PHARMACEUTICALS label
NDC #11694-720-20 for KEY COMPANY label
8&9.. Gentamicin Sulfate Injection, USP, 80 mg/2 mL, 2 mL vial;
and Gentamicin Sulfate Injection, USP, 40 mg/mL, 20 mL vial, NDC
#0402-0559-02 for STERIS LABS label [2 ml SIZE] NDC #0364-6739-48
for SCHEIN PHARMACEUTICAL label [2 ml SIZE] NDC #66467-4685-9 for
DARBY GROUP label [2 ml SIZE] NDC #0182-1424-61 for ZENITH-
GOLDLINE LABORATORIES label NDC #0536-4690-67 for RUGBY
LABORATORIES label [2 ml SIZE] NDC #0839-6503-23 for MOORE
MEDICAL label [2 ml SIZE]
NDC #0402-0559-20 for STERIS LABS label [20 ml SIZE]
NDC #0182-1424-65 for ZENITH-GOLDLINE LABORATORIES label [20 ml
SIZE] NDC #66467-4685-2 for DARBY GROUP label [20 ml SIZE] NDC
#0364-6739-55 for SCHEIN PHARMACEUTICAL label [20 ml SIZE] NDC
#0536-4690-73 for RUGBY LABORATORIES label
10. Metoprolol Tartrate Injection, USP, 5 mg/5mL, 5 mL vial, NDC
#0364-3036-25 for SCHEIN PHARMACEUTICAL label
11. Neomycin and Polymyxin B Sulfates Solution for Irrigation,
USP, 1 mL Ampul, NDC #0364-2190-41 for SCHEIN PHARMACEUTICAL
label
12. Phenylephrine Hydrochloride Ophthalmic Solution, USP, 10%, 5
mL dropper bottle, NDC #0402-0799-05 for STERIS LABS label
NDC #0364-2370-53 for SCHEIN PHARMACEUTICAL label
NDC #51394-226-10 for WILSON OPHTHALMICS label
NDC #54799-531-05 for OCUSOFT label
13. Vecuronium Bromide for Injection 10 mg, lyophilized powder,
10 mL vial, NDC #0209-9140-22 for MARSAM PHARMACEUTICAL label
NDC #0209-9140-92 for MARSAM PHARMACEUTICAL label
NDC #0209-9141-26 for MARSAM PHARMACEUTICAL label
14. Vecuronium Bromide for Injection 20 mg, lyophilized powder,
20 mL vial, NDC #0209-9143-22 for MARSAM PHARMACEUTICAL label
NDC #0209-9143-92 for MARSAM PHARMACEUTICAL label.
Recall #D-114/127-0.
CODE
Lot Numbers:
1. 96H760 97C790 97G780 98A070
2. 98C840 98D140 98D360 98D580
3. 97C580
4. 96N430 97D950 98B530
5. 97L910
6. 97K710 98B550 97J410 97J510
7. 96K880 96F890 96M330 96M700
96N600 96N750 97A150 97A650
97B010 97E260 97E410 97G060
97K510 98B310 98C050 98C670
96N740 97A510 97B500
8&9 [for 2 ml SIZES]: 96K870 97B550 97G240
[for 20 ml SIZES]: 97A570 97C210 97G290
10. 97J300 97J350 97J360 97J590 97K470
97L290 97M320 98A910 98B570
98C250 98C890 98D150 98D380
98E120 98D740 98E530 98F150
11. 96L260 97B320 97B910 97F160
97F220 97J110 97J320 98A350
98A830 98B190
12. 96L290 97C660 97J100 97J840 98D880
13. 98B770 98C150 98C270 98C340
98C530 98C700 98D080 98D200
98D250 98D300 98D460 98D621
98D760 98E190 98E350 98E600
98E880 98F010 98F090 98F180
14. 98B780 98C390 98D110 98D260
98D770 98E220 98E640.
MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY
Manufacturer, by letter dated October 8, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
1. 64,689 units
2. 71,930 units
3. 30,797 units
4. 64,151 units
5 10,494 units
6. 91,684 units
7. 1,322,117 units
8&9) 439,139 units
10. 1,015,520 units
11. 876,375 units
12. 150,242 units
13. 854,561 units
14. 72,130 units
REASON
Current good manufacturing practice deviations - Lack of data to
support process validation(s) and defect investigations.
________
PRODUCT
Diabeta® (Glyburide) 5mg, 100 tablet bottles, Rx, for use as an
adjunct to diet to lower the blood glucose in patients with non
insulin-dependent diabetes mellitus (Type II), packaged in 24
bottles/intermediate box, 4 intermediate boxes/shipping case. NDC
#0039-0052-10.
Recall #D-130-0.
CODE
Lot Number 0017181, EXP 6/2001.
MANUFACTURER
Med-Pro, Inc., Lexington, Nebraska (repacker).
RECALLED BY
Repacker, by telephone on September 27, 1999, and by letter dated
September 28, 1999. Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
840 100-tablet bottles were distributed.
REASON
Immediate bottle label shows two strengths 5 MG and 25 MG.
________
PRODUCT
Compressed Medicinal Oxygen in Steel Tanks, (E, D, and M size),
Rx drug for breathing therapy. Recall #D-142-0.
CODE
Various lots produced between 8/7/98 and 8/17/99.
MANUFACTURER
Option Care, Covington, Georgia.
RECALLED BY
Manufacturer, by telephone on November 5, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Georgia.
QUANTITY
6,000 cylinders were distributed.
REASON
Current good manufacturing practice deviations, including but not
limited to lack of oxygen assays.
________
PRODUCT
M.V.I.® Pediatric (Multiple Vitamins for infusion), in 10 mL
Single Dose Vial. Recall #D-144-0.
CODE
Lot Numbers 9F3009, EXP 3/00, 9F3011 EXP 4/00.
MANUFACTURER
Catalytica Pharmaceuticals, Greenville, North Carolina.
RECALLED BY
AstraZeneca Inc., Westborough, Massachusetts, by letter dated
November 18, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Tennessee, Arizona.
QUANTITY
9,163 units of Lot #9F3009 and 9,143 units of Lot #9F3011 were
distributed.
REASON
Subpotent (vitamin A, K, Dexpanthenol and/or Pyridoxine).
RECALLS AND FIELD CORRECTIONS: CLASS III
________
PRODUCT
Triamcinolone Acetonide Cream 0.1% in 1 pound jars, under the
following labels: NMC Laboratories; - NDC 23317-301-16; Rugby
Laboratories - NDC 0536-5225-98;
Major Pharmaceuticals, - NDC 0904-2741-27
Schein Pharmaceuticals - NDC 0364-7212-16.
Recall #D-128-0.
CODE
Lot # EXP Label
6I561 09/99 NMC
6K705 11/99 Rugby
6I571 09/99 NMC
6K707 11/99 Rugby
6I576 09/99 NMC
6K715 11/99 NMC
6I578 09/99 NMC
6K716 11/99 NMC
6I581 09/99 NMC
6K724 11/99 NMC
6I623 09/99 NMC
6K750 11/99 NMC
6J626 10/99 NMC
6L744 12/99 NMC
6J627 10/99 NMC
6L775 12/99 NMC
6J636 10/99 NMC
6L793 12/99 NMC
6J657 10/99 Major & NMC
6L794 12/99 NMC
6L820 12/99 NMC
6J673 10/99 NMC
7A847 01/00 NMC
6J674 10/99 Schein
MANUFACTURER
Alpharma USPD, Inc., Lincolnton, North Carolina.
RECALLED BY
Manufacturer, by letter on or about September 13, 1999. Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
102,381 units were distributed; firm estimated that very little
product remained on market at time of recall initiation based on
EXP dates.
REASON
Lack of assurance that product will meet potency specification
over labeled expiration date (superpotency).
________
PRODUCT
Clobetasol Propionate Topical Solution, USP, 0.05%, in 25 and 50
mL bottles, Rx used as a topical treatment of inflammatory and
pruritic manifestations of moderate to severe corticosteroid-
responsive dermatoses of the scalp. Recall #D-129-0.
CODE
Lot Size (mL) Exp
RJ7557 50 9/99
RJ7558 50 9/99
VK7642 50 9/99
VL7660 50 10/99
VN7754 25 11/99
VN7754 50 11/99 (H.L.Moore)
RP7931 25 11/99
RP7931 50 11/99
RS7974 25 01/00
RS7974 50 01/00
RA8012 50 03/00
RB8028 25 05/00
RA8057 25 02/00
RB8069 50 03/00
RH8170 50 06/00
RC8212 50 05/00
RF8413 50 06/00.
MANUFACTURER
Alpharma USPD, Inc., Baltimore, Maryland.
RECALLED BY
Manufacturer, by letter on or about September 10, 1999. Firm-
initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
345,462 units under Alpharma label and 3,564 units (50 mL) under
the H.L. Moore label were distributed.
REASON
Exceeding USP total related substances testing prior to
expiration date.
________
PRODUCT
Norco Tablets 10mg/325 mg Hydrocodone Bitartrate/ Acetaminophen,
Physician Samples, Cartons of 30’s containing 15 units of 2
tablets, Rx indicated for the relief of moderate to moderately
severe pain in humans.
NDC #52544-539-30. Recall #D-131-0.
CODE
LOT NUMBER EXPIRATION DATE
53902R96F 11/1998
53903R96F 11/1998
53901R96F 11/1998
53904R96F 11/1998
53904J98F 09/2000
53903M98F 10/2000
53910M98F 10/2000
53901R98F 11/2000
53904R98F 11/2000
53901A99F 01/2001
53902A99F 01/2001
53903A99F 01/2001
53904A99F 01/2001
53901C99F 03/2001.
MANUFACTURER
Watson Laborataories, Inc., a subsidiary of Watson
Pharmaceuticals, Inc., Corona, California.
RECALLED BY
Manufacturer, by letter on October 14, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
222,472 cartons (15 2-tablet pouches per carton) were
distributed.
REASON
Labeling lacks approval.
________
PRODUCT
Klonopin (brand of Clonazepam) Tablets, in bottles of 100 tablets
Rx used in the treatment of seizure disorders:
a) 0.5 mg, NDC `0004-0068-01; b) 1.0 mgm,
NDC #0004-0058-01; c) 2.0 mg, NDC #0004-0098-01.
Recall #D-132/134-0.
CODE
LOT NO. EXP DATE
U0003 11/2000
U0004 11/2000
U0501 12/2000
U0502 12/2000
U1002 11/2000.
MANUFACTURER
Roche Pharma, Inc., Humacao, Puerto Rico.
RECALLED BY
Roche Laboratories, Inc., Nutley, New Jersey, by telephone on
September 3, 1999, followed by letter. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Approximately 79,013 units of all three strengths were
distributed.
REASON
Product had incorrect expiration date on label.
________
PRODUCT
Lidocaine and Epinephrine Injection, USP (Lidocaine HCl 2% and
Epinephrine 1:100,000 and 1:50,000) and Mepivacaine Hydrochloride
and Levonordefrin Injection, USP (Mepivacaine HCl 2% and
Levonordefrin 1:20,000). The products are shipped in 1.8 ml
cartridges with 50 cartridges per box.
Recall #D-135/137-0.
CODE
a) Lidocaine 100:
Lot # 8050 EXP 10/99 under Novocol label (distributed by
Septodont, Inc)
Lot # 8051 EXP 10/99 under Novocol label (distributed by
Septodont, Inc)
Lot # 8055* EXP 10/99 under Henry Schein label
Lot # 8056* EXP 10/99 under Henry Schein label
Lot # 8057 EXP 10/99 under Henry Schein label
Lot # 8064 EXP 10/99 under Henry Schein label
Lot # 8065 EXP 10/99 under Henry Schein label
Lot # 8066 EXP 10/99 under Meer Dental label
Lot # 8067 EXP 10/99 under Carlisle Laboratories label
Lot # 8068 EXP 10/99 under Novocol label (distributed by
Septodont, Inc)
Lot # 8069 EXP 10/99 under Novocol label (distributed by
Septodont, Inc)
Lot # 8071 EXP 10/99 under Meer Dental label
Lot # 8072 EXP 11/99 under Meer Dental label
Lot # 8073 EXP 11/99 under Novocol label (distributed by
Septodont, Inc)
Lot # 8074* EXP 11/99 under Carlisle Laboratories label
Lot # 8075 EXP 11/99 under Carlisle Laboratories label
Lot # 8076 EXP 11/99 under Carlisle Laboratories label
Lot # 8077 EXP 11/99 under Carlisle Laboratories label
Lot # 8078 EXP 11/99 under Carlisle Laboratories label
Lot # 8079 EXP 11/99 under Carlisle Laboratories label
Lot # 8080* EXP 11/99 under Carlisle Laboratories label
Lot # 8081* EXP 11/99 under Carlisle Laboratories label
Lot # 8082* EXP 11/99 under Carlisle Laboratories label
b) Lidocaine 50:
Lot # 8058 EXP 10/99 under Novocol label (distributed by
Septodont, Inc)
Lot # 8059C EXP 10/99 under Novocol label (distributed by
Septodont, Inc)
Lot # 8060 EXP 10/99 under Henry Schein label
Lot # 8083 EXP 11/99 under Carlisle Laboratories label
Lot # 8086B* EXP 11/99 under Patterson Dental label
c) Mepivacaine 2%:
Lot # 8063B EXP 10/99 under Meer Dental label (Henry Schein now
owns)
Lot # 8063C EXP 10/99 under Novocol label (distributed by
Septodont, Inc)
Lot # 8063D EXP 10/99 under Carlisle Laboratories label
* Indicates that the lot was involved in recall D-188/91-9.
MANUFACTURER
Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario,
Canada.
RECALLED BY
Septodont, Inc., New Castle, Delaware, by telephone on September
27, 1999, and by letter on October 1, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
52 boxes.
REASON
Subpotent (Ephinehrine/Levonordefrin).
________
PRODUCT
Pepcid (Famotidine) Tablets, 20 mg repacked in unit dose
blisters, Rx, overpackaged by Haines Pharmaceuticals.
NDC #0006-0963-28. Recall #D-138-0.
CODE
Lot #4616 EXP 10/99.
MANUFACTURER
Haines Pharmaceuticals Division, IMDS, Inc., Pompano Beach,
Florida (repacker/responsible firm).
RECALLED BY
AmeriSource Health Services Corporation, doing business as
American Health Packaging, Columbus, Ohio, by letter faxed on
October 29, 1999. Firm-initiated recall complete.
DISTRIBUTION
Ohio, Massachusetts, Tennessee.
QUANTITY
750 bags (75,000 individual units) were distributed; firm
estimates none remains on the market.
REASON
Repacking error - Some units may contain a multivitamin.
________
PRODUCT
Tebamide (tm) Suppositories (Trimethobenzamide), 200 mg, in boxes
of 10 and 50, Rx used to control nausea and vomiting.
Recall #D-139-0.
CODE
Product Code 0108
Lot Numbers EXP Date NDC Numbers Label
7025-5 02/00 0713-0108-50 G & W (50s)
0713-0108-09 G & W (10s)
0904-2736-15 Major (I Os)
0364-7348-10 Schein (I Os)
7072-5 03/00 0713-0108-09 G & W (10s)
0904-2736-15 Major (I Os)
0364-7348-10 Schein (1 Os)
7226-2 09/00 0713-0108-09 G & W (10s)
0364-7348-10 Schein (I Os)
8173-1 07/01 0713-0108-09 G & W (10s)
0713-0108-50 G & W (50s)
0904-2736-15 Major (I Os)
0364-7348-10 Schein (I Os)
8173-2 07/01 0713-0108-09 G & W (10s)
0713-0108-50 G & W (50s).
MANUFACTURER
G&W Laboratories, Inc., South Plainfield, New Jersey.
RECALLED BY
Manufacturer, by letters on June 11, 1999, and August 25, 1999.
Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
Lot Number Package Size Units/Boxes Distributed
7025-5 50's 1,896 units
7025-5 10's 29,160 units
7072-5 10's 37,872 units
7226-2 10's 38,448 units
8173-1 10's 26,088 units
8173-1 50's 1,800 units
8173-2 10's 32,256 units
8173-2 50's 1,296 units.
REASON
Subpotency of Benzocaine and/or lack of assurance Benzocaine
levels will remain within specification over labeled expiration
date.
________
PRODUCT
Fluocinonide Cream USP, 0.05%, in 30 gram tubes, Rx used as a
topical corticosteroid, which has anti-inflammatory, anti-prurtic
and vasoconstrictive actions. Recall #D-141-0.
CODE
Lot #7F306 EXP 6/00.
MANUFACTURER
Taro Pharmaceuticals, Bramalea, Ontario, Canada.
RECALLED BY
Taro Pharmaceuticals USA, Inc., Hawthorne, New York, by letter
dated August 19, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Arkansas, Arizona, California, Colorado, Connecticut, Georgia,
Illinois, Louisiana, Maine, Minnesota, New Jersey, New York,
Pennsylvania, Tennessee.
QUANTITY
10,032 30-gram tubes were distributed.
REASON
Subpotency at 24 month stability.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________
PRODUCT
CMS ACCUPROBE 530,a cryosurgical system used for controlled
ablation and destruction of malignant/benign tissue in the body.
Device supercools liquid nitrogen applied to tissue for
destruction. Recall #Z-215-0.
CODE
Serial Numbers: 530-1001 to 530-1019.
MANUFACTURER
Cryomedical Sciences, Inc., Rockville, Maryland.
RECALLED BY
Manufacturer, by visit April 29, 1999, or by telephone and letter
October 29, 1999. Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
19 systems were distributed.
REASON
Device wiring found to be corroded, burned, or fatigued.
________
PRODUCT
Toxo IgM Enzyme-Linked Immunosorbent Assay (ELISA)
a) Product No. 1029-315Z, Toxo IgM ELISA - 96 Tests;
b) Product No. B1029-315Z, Toxo IgM ELISA.
Recall #Z-219/220-0.
CODE
Lot Numbers: a) 1S&T010880 EXP 06-30-00;
b) 8TOXO02918 EXP 02-24-00.
MANUFACTURER
Zeus Scientific, Inc., Branchburg, New Jersey.
RECALLED BY
Manufacturer, by letter sent April 9, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Washington state.
QUANTITY
a) 30 kits; b) 25 kits were distributed; firm estimates none
remains on the market.
REASON
Device may produce high rates of false positive test results.
________
PRODUCT
Procedure Based Delivery Systems Module, used in surgery,
composed of subassembly kits, including the set up subassembly
kit, which contains a skin/scrub prep tray that had latex gloves
packaged in the tray; Packaged by Allegiance Healthcare
Corporation. Recall #Z-221/224-0.
CODE
Skin/Scrub Prep Tray contained in Set Up subassembly kit
PZ90LFCSC contained in the following modules manufactured between
9/9/99 and 11/8/99:
Module PG90MALFC, PBDS Pathways General Surgery Latex Free Kit;
Module PL90CSLFB, PBDS Pathways C-Section Latex Free Kit; Module
PN90CYLFB, PBDS Pathways Neurosurgery Latex Free Kit; Module
PO90MJLFB, PBDS Pathways Orthopedic Latex Free Kit.
MANUFACTURER
Allegiance Healthcare Corporation, Montgomery, New York.
RECALLED BY
Allegiance Healthcare Corporation, McGaw Park, Illinois, by
letter dated November 12, 1999. Firm-initiated recall ongoiong.
DISTRIBUTION
Nationwide.
QUANTITY
138 modules.
REASON
Kits labeled as latex free contain latex gloves.
________
PRODUCT
PACEART CardioVoice Telephones include:
a) CardioVoice Speaker Phone, Model No. CVP-1A;
b) CardioVoice Trimline Phone, Model No. CVP-1;
c) CardioVoice Portable Transmitters (or CardioVoice Phone
Portable Option), a compact real-time transmitter that can send a
patient's real-time electrocardiogram (ECG) to a receiving center
at a physician's office or a specialized monitoring service from
any location, Model No. CT-1.
Recall #Z-227/229-0.
CODE
a) Sale Code: CVP-1A; b) Sale Code: CVP-1;
c) Sale Code: CT-1. All units shipped to consignees between
5/1/98 to 7/15/99.
MANUFACTURER
PACEART Associates, L.P., Fairfield, New Jersey.
RECALLED BY
Manufacturer, by letters dated March 9, 1999, and July 15, 1999.
Firm-initiated field correction ongoing.
DISTRIBUTION
a) California, Florida, Georgia, Missouri, New York, Ohio,
Washington state, China; b) Alabama, Delaware, Kansas, Kentucky,
Missouri, Michigan, New Jersey, New York, Ohio, Texas, China, and
England; c) California, District of Columbia, Florida, Kentucky,
Louisiana, Massachusetts, Maryland, Missouri, New Jersey, New
York, Oregon, Pennsylvania, Virginia, Washington state,
Australia.
QUANTITY
Undetermined.
REASON
The devices fail to comply with the performance standard for
electrode lead wires and patient cables, 21 CFR 898.
________
PRODUCT
Medtronic GEM Implantable Cardioverter Defibrillators:
a) Medtronic GEM Model No. 7227Cx Implantable Cardioverter
Defibrillator;
b) Medtronic GEM Model No. 7229Cx Implantable Cardioverter
Defibrillator. Recall #Z-230/231-0.
CODE
All serial numbers ending with the letter "H".
MANUFACTURER
Medtronic Med Rel, Inc., Humacoa, PR.
RECALLED BY
Medtronic, Inc., Minneapolis, Minnesota, by letter dated October
15, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
a) 9654; b) 44 units were distributed.
REASON
Improper P+ wire routing and less than required silicone adhesive
insulation on the P+ wire in the connector module.
________
PRODUCT
Cryolife Allograft Heart Valve: a) Model AVOO;
b) Model PVOO. Recall #Z-232/233-0.
CODE
Serial Numbers: a) 6272991; b) 6273009.
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter on October 15, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Ohio and California.
QUANTITY
2 units.
REASON
The liver from the donor of the allografts had been diagnosed
with cancer.
________
PRODUCT
K-1 Infant Transport Incubators:
a) Transport Incubator 100 - Globetrotter (GT67);
b) Transport Incubator 100 - Trailblazer (TB67);
c) Transport Incubator 100 - Roadrunner (RR67);
d) Transport Incubator 500 - Globetrotter (GT500).
Recall #Z-234/237-0.
CODE
Various serial numbers.
MANUFACTURER
Hill-Rom Air-Shields, Hatboro, Pennsylvania.
RECALLED BY
Manufacturer, by visit beginning October 15, 1999, and by letter.
Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
568 units were distributed.
REASON
The devices have a faulty design of the hand ventilator which
does not indicate the true pressure in the incubator.
________
PRODUCT
CAPTIA Rubella-M, Product No. 800-920, used for the detection of
IgM antibodies to rubella in human serum as an aid to the
diagnosis of recent or current rubella infection. Recall #Z-238-0.
CODE
Lot Numbers: 34K2029 EXP 18-MAR-00; 34K0358 EXP 18-MAR-00; and
34K2019 EXP 15-APR-00.
MANUFACTURER
Trinity Biotech plc, Bray, Co. Wicklow, Ireland
RECALLED BY
Manufacturer, by letter October 22, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
296 kits.
REASON
The High Titre Positive (HTP) Control is reading below the stated
Optical Density value of >0.9 for the HTP in the kit labeling.
________
PRODUCT
Sarns 3M Centrifugal Pump, Catalog No. 164275.
Recall #Z-240-0.
CODE
Lot No. W504470 and W504471.
MANUFACTURER of Plastic Pouches
Kenpak, City of Commerce, California.
RECALLED BY
Terumo Cardiovascular Systems Corporation, Ann Arbor, Michigan,
by telephone and faxed letter dated November 9, 1999. Firm-
initiated recall ongoing.
DISTRIBUTION
Arizona, California, Florida, Indiana, Kansas, Louisiana,
Massachusetts, Michigan, Mississippi, Missouri, New Hampshire,
New Jersey, Pennsylvania, Pureto Rico, Rhode Island, Texas, Utah,
District of Columbia, Wisconsin.
QUANTITY
960 units were distributed.
REASON
Some of the pouches had weak areas near the seams and, post-
sterilization, sampling found some pouches had opened up.
________
PRODUCT
Abbott ACCLAIM Infusion Pump and Abbott ACCLAIM Encore Infusion
Pump Model: 12032-04 and 12237-04.
Recall #Z-244/245-0.
CODE
None.
MANUFACTURER
Abbott Laboratories, Inc., Morgan Hill, California.
RECALLED BY
Manufacturer, by letter on November 17, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
2,005 units.
REASON
Failure of the temperature compensation sensor circuit can lead
to inaccurate delivery.
________
PRODUCT
Allograft Heart Valves. Recall #Z-248/249-0.
CODE
Model Number AV00 - Serial Number 6267068
Model Number PV00 - Serial Number 6267033
Model Number AV05 - Serial Number 3978516
Model Number PV05 - Serial Number 3978524
Model Number PV00 - Serial Number 6276466
Model Number AV00 - Serial Number 6206476
Model Number AV00 - Serial Number 6003915.
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter sent on November 8,9, and 11, 1999.
Firm-initiated recall complete.
DISTRIBUTION
California, Massachusetts, Michigan, Nebraska, New Hampshire,
Tennessee, Texas.
QUANTITY
7 units.
REASON
Donors do not meet current guidelines regarding serodilution of
plasma.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________
PRODUCT
CryoLife Allograft Heart Valve, Model No. AVOO.
Recall #Z-225-0.
CODE
Serial #6635253.
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by telephone on October 7, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Nevada.
QUANTITY
1 unit.
REASON
Additional donor information not available at the time of initial
donor and tissue review by quality assurance indicates the donor
had viral mycocarditis at the time of death.
________
PRODUCT
Datascope Safety Guidewire, Size .020"x145cm, used in conjunction
with the firm's 8 French Intra Aortic Balloon (IAB) Catheters.
Recall #Z-239-0.
CODE
Catalog #0684-00-0254-04.
MANUFACTURER
Datascope Corporation, Cardiac Assist Division, Fairfield, New
Jersey.
RECALLED BY
Manufacturer, by telephone from September 21, 1999 - October 5,
1999. Firm-initiated recall complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
46 10-packs were distributed.
REASON
Size .030" guidewire was found in the .020" guidewire package.
________
PRODUCT
Disposable Argon Plasma Coagulation (APC) Probe for Flexible
Endoscopy, single use sterile probes:
a) Part Number 20132-071; b) Part Number 20132-072.
Recall #Z-241/242-0.
CODE
a) Lot Number A070535; b) Lot Number A070535.
MANUFACTURER
ERBE, Tubingen, Germany.
RECALLED BY
ERBE USA, Inc., Marietta, Georgia, by letter on October 26, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
2,031 probes were distributed.
REASON
Some of APC Probes may have an incorrect label on the pouch. The
pouch has two labels, one international label (four languages)
and one US label (English only). The international label may have
an incorrect part number and probe diameter. The US label is
correct.
MEDICAL DEVICE SAFETY ALERTS:
________
PRODUCT
PCA I and PCA II Syringe Infusion Pumps, capable of both
continuous and intermittent infusion of parenteral fluids with a
Patient Controlled Analgesia mode intended primarily for the
infusion of analgesics into the patient upon the patient's
request by use of the patient button.
Safety Alert #N-003/004-0.
CODE
All Baxter PCA Sets without anti-siphon technology used with both
the Baxter PCA I Syringe Infusion Pump, Product Code 2L3103 and
Baxter PCA II Syringe Infusion Pump, Product Code 2L3104.
The affected sets without anti-siphon technology are of the
following product codes:
2C9205 - Baxter Tamper Resistant PCA Extension Set,
Volume 0.8 mL, Length 60", also marketed under
6466500
2C9206 - Baxter Tamper Resistant PCA Extension Set,
Volume 1.2 mL, Length 96"
2L3507 - Baxter Tamper Resistant PCA Combination Set,
Volume 2.5 mL, Length 101".
MANUFACTURER
Baxter Healthcare Corporation, Aibonito, Puerto Rico.
The Aibonito, PR plant manufactures the sets. The PCA I
pumps were made by Baxter at their North Reading, MA plant,
and the PCA II pumps are made by Baxter at their Singapore
plant.
ALERTED BY
Baxter Healthcare Corporation, Round Lake, Illinois, by letter
dated November 10, 1999. Firm initiated, ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
22,800 pumps.
REASON
Uncontrolled flow of medication if user improperly loads syringe
into PCA pump.
END OF ENFORCEMENT REPORT FOR DECEMBER 15, 1999. BLANK PAGES MAY
FOLLOW.
####
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