February 26, 2003
03-09
_____________________________
PRODUCT
Assorted Truffles. 1 lb. bag labeled as "Harry and David Truffles Truffle Assortment Milk Chocolate, Cherry and Coffee. Recall # F-205-3.
CODE
3052 and 3062 (first 3 digits represent Julian date, 4th digit is year) best if used by 09/28/03.
RECALLING FIRM/MANUFACTURER
Harry and David, Medford, OR, by telephone on January 10, 2003 and press release on January 14, 2003. Firm initiated recall is complete.
REASON
Truffles contain undeclared almonds and hazelnuts.
VOLUME OF PRODUCT IN COMMERCE
6,600/1 lb. bags.
DISTRIBUTION
Nationwide.
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PRODUCT
Johnson's Chocolates Sugar Free Net WT. 16 oz. Box contains a variety of chocolate candies. Recall # F-206-3.
CODE
2112.
RECALLING FIRM/MANUFACTURER
Johnson Candy Co., Tacoma, WA, by telephone on December 4, 2002. FDA initiated recall is complete.
REASON
The product may contain undeclared ingredients including peanuts and tree nuts, and undeclared color, FD&C Red No 3.
VOLUME OF PRODUCT IN COMMERCE
27/1 lb. boxes.
DISTRIBUTION
WA.
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PRODUCT
a) No Sugar added Yellow Cake, Net Wt. 17 oz. (482 g).
Decorated yellow cake in an aluminum pan with clear plastic lid, packaged in cases of 6 yellow cakes - item 14009 and in cases marked Assorted - item 14806, which consist of 3 yellow cakes and 3 chocolate cakes.
Recall # F-108-3;
b) Sugar Free Yellow Cupcakes, Wt. 8 oz. (224g).
UPC 14821-17009 Decorated yellow cupcakes in cupcake
papers, 4 cupcakes per clear plastic clamshell retail
container. The retail containers are packaged in cases
of 12 - item 17009, and in cases marked Assorted - item
17806, which consist of 6 yellow cupcake packages and 3
chocolate cupcake packages. Recall # F-109-3.
CODE
a) UPC #14821-14009, all products distributed between
5/1/02 and 10/30/02.
b) UPC #14821-1009, all products distributed prior to
11/14/02.
RECALLING FIRM/MANUFACTURER
Nancy's Pies, Inc., Rock Island IL, by letter dated November 14, 2002. State initiated recall is ongoing.
REASON
The products contain an undeclared color, FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE
a) 33,030 cakes;
b) 28,284 packages of 4 cupcakes.
DISTRIBUTION
Nationwide.
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PRODUCT
Gonal-F (follitropin alfa for injection) 1200 IU Multi-dose vial for injection copackaged with one pre-filled syringe containing 2 mL Bacteriostatic Water for Injection, USP, Rx Only, For subcutaneous use, NDC 44087-1200-1.
Recall # D-123-3.
CODE
Gonal F lot numbers: BK006A, BK007A, BK008B, BK009A, BK010B, BK012A, BK013A
(Prefilled Syringe Diluent Lot Numbers: 1-BEX-701, 1-BEX-702, and 2-BEX-701).
RECALLING FIRM/MANUFACTURER
Serono Laboratories, Inc, Rockland, MA, by letter dated November 21, 2002. Firm initiated recall ongoing.
REASON
Lack of assurance of sterility for the copackaged pre-filled diluent syringes(manufactured by Schering Plough Corporation) copackaged with Gonal-F.
VOLUME OF PRODUCT IN COMMERCE
92,653 units.
DISTRIBUTION
Nationwide.
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PRODUCT
Codimal DM Syrup, For Cough/Colds,(Dextromethorphan hydrobromide 10 mg, Phenylephrine
hydrochloride 5 mg, and Pyrilamine maleate 8.33 mg) 118mL (4 Fl oz) and 473mL
(1 Pint) bottles. Recall # D-125-3.
CODE
a) Lot 1125601 NDC#0131-5131-70 - 473mL (1 Pint) bottles,
b) Lot 1125602 NDC#0131-5131-64 - 118mL (4 Fl oz) bottles.
RECALLING FIRM/MANUFACTURER
Schwarz Pharma Manufacturing, Seymour, IN, by letter on December 3, 2002. Firm
initiated recall is ongoing.
REASON
Cross contamination-product contains traces of iron from another oral iron product.
VOLUME OF PRODUCT IN COMMERCE
a) 706 bottles;
b) 23,683 bottles.
DISTRIBUTION
Nationwide and Guyana, Jamaica, Peru, Dominican Republic, Chile, and Uraguay.
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PRODUCT
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5mg/500mg, 100 count bottle, Rx only. Recall # D-127-3.
CODE
Lot # 062121C.
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, NC, by letter on October 28, 2002. Firm initiated recall is complete.
REASON
Mislabeled; label incorrectly printed with Scheduled Drug Classification as CIV instead of correctly as CIII.
VOLUME OF PRODUCT IN COMMERCE
1079 bottles (100 tablets per bottle).
DISTRIBUTION
Nationwide.
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PRODUCT
a) Aerozoin,Skin Conditioner For Tape & Cast Dressings,
(Tinture of Benzoin, USP 40%), Net Wt. 3.5 oz., spray
can. Recall # D-128-3;
b) KENZOIN, Skin Conditioner For Tape & Cast Dressings,
(Tinture of Benzoin, USP 40%), Net Wt. 4 oz. (113 Grams).
Recall # D-129-3.
CODE
a) Aerozoin Lots: 1082902 Exp. 8/05; 1083002 Exp. 8/05;
1090302 Exp. 9/05; 2137 Exp. 7/05; 2137-2 Exp.7/05; 2137-3 Exp 7/05; 2137-4 Exp 7/05; 2137-5 Exp 7/05; 2137-6 Exp 7/05; 2137-7 Exp 7/05;
b) Kenzoin Lot: 2036 Exp. 2/05.
RECALLING FIRM/MANUFACTURER
Pel Associates, Inc, North Branch, NJ, by letter and fax on November 8, 2002. Firm initiated recall is ongoing.
REASON
Failure to comply with Good Manufacturing Practice Regulations including performance of finished product assays & manufacturing validation.
VOLUME OF PRODUCT IN COMMERCE
102,864 cans (Aerozoin and Kenzoin).
DISTRIBUTION
Nationwide.
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PRODUCT
Red Blood Cells, Autologous. Recall # B-0433-3.
CODE
Unit 18FT57961.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on March 6, 2002. Firm initiated recall is complete.
REASON
Blood product, manufactured from an overweight Whole Blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced, Irradiated.
Recall # B-0532-3.
CODE
Units 0827635, 0827636, 0823388.
RECALLING FIRM/MANUFACTURER
Blood Center of the Pacific, San Francisco, CA, by letter dated May 16, 2001, July 18, 2001 or July 19, 2001. Firm initiated recall is complete.
REASON
Blood products, for which documentation of irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0533-3.
CODE
Units 53R04400, 53R01570.
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by
letter dated September 27, 2002 or November 7, 2002. Firm initiated recall is
complete.
REASON
Blood products, collected from a donor who reported having lived in an area
designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and DC.
***CORRECTION***
Enforcement Report for February 19, 2003, (03-08), the recall listing for Baxter, Recall # Z-0504-3/0523-3, list Baxter Healthcare, Corp., Deerfield, IL., as the manufacturer, the correct manufacturer is Baxter Healthcare, Corp., Cleveland, MS., and Baxter Healthcare, Corp., Albonito, PR.
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PRODUCT
Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems .
Recall # Z-0157-03.
CODE
All serial numbers in distribution at the time of the recall.
RECALLING FIRM/MANUFACTURER
General Electric Med Systems, Waukesha, WI, by field modification instructions on November 21, 2002. Firm initiated recall is ongoing.
REASON
The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels.
VOLUME OF PRODUCT IN COMMERCE
78 devices.
DISTRIBUTION
Nationwide.
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PRODUCT
Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free procedure tray containing a 7" long Thoracentesis Catheter with a 14 gauge x 2" needle, catheter guard, 60 ml syringe, needles, 5 ml syringe, drainage tube with needle, fluid collection bag, three prelabeled specimen vials with caps, 2 swab sticks, three gauze pads, fenestrated drape with adhesive strips, towel, 5 ml -1% lidocaine hydrochloride, hospital wrap and bandage. Recall # Z-0420-03.
CODE
L1J035X, L1J088, L1K042, L1K058, L1K070, L1L057X, L1N018, L1N031, L1N039X, L1N094, L1P017, L1P045, L1S015, L2A012, L2A021, L2A048, L2A075, L2B039, L2B047 ,L2B073, L2C012, L2C038, L2C083, L2D041, L2D067, L2E036
RECALLING FIRM/MANUFACTURER
Recalling Firm: Allegiance Healthcare, Corp., McGaw Park, IL, by letters dated November 15,2002.
Manufacturer: Allegiance Healthcare, Corp., Mannford, OK. Firm initiated recall is ongoing.
REASON
Raw material used in the manufacture of catheters may contain a contaminant predisposing the catheter to become brittle, possibly breaking during use.
VOLUME OF PRODUCT IN COMMERCE
123,050 trays.
DISTRIBUTION
Nationwide.
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PRODUCT
a) Y-Type Blood/Solution Set, catalog #1C8029; Standard
Blood Filter (170 to 260 micron), Drip Chamber Pump,
Injection Site, Male Luer Lock Adapter, 111'' long, 10
drops per mL. Recall # Z-0448-03;
b) Y-Type Blood/Solution Set, catalog #1C8117; Standard
Blood Filter (170 to 260 micron), Drip Chamber Pump,
Injection Site, Male Luer Lock Adapter, 88'' long,
10 drops per mL. Recall # Z-0449-3.
c) Y-Type Blood/Solution Set, catalog #1C8372; Standard
Blood Filter (170 to 260 micron), Drip Chamber Pump,
2 Injection Sites, Male Luer Lock Adapter, 111'' long,
10 drops per mL. Recall # Z-0450-3;
d) Y-Type Blood/Solution Set, catalog #1C8459; Standard
Blood Filter (170 to 260 micron), Drip Chamber Pump,
3 Injection Sites, Male Luer Lock Adapter, 111" long,
10 drops per mL. Recall # Z-0451-3;
e) Y-Type Blood/Solution Set with Pressure Pump, catalog #1C8658; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 109" long, 10 drops per mL. Recall # Z-0452-3.
CODE
a) Lots GR182881, GR183558, GR184200, GR185900;
b) Lot GR183715;
c) Lots GR183152, GR183483, GR184622, GR185652;
d) Lots GR182873, GR185678;
e) GR184184, GR186551.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated December 18, 2002.
Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing.
REASON
Leakage may occur at the inlet port.
VOLUME OF PRODUCT IN COMMERCE
a) 21,134 sets;
b) 3,792 sets;
c) 42,330 sets;
d) 4,320 sets;
e) 1,392 sets.
DISTRIBUTION
Nationwide.
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PRODUCT
Stryker brand Neptune waste management system, model 711-27-1. Recall # Z-0524-03.
CODE
All systems with a rover top cap assembly 711-27-001 manufactured from 1/1/01 to 12/31/01.
RECALLING FIRM/MANUFACTURER
Stryker Instruments, Instruments Div., Kalamazoo, MI, by telephone, beginning on December 3, 2002, and by letter dated December 6, 2002. Firm initiated recall is complete.
REASON
Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.
VOLUME OF PRODUCT IN COMMERCE
370.
DISTRIBUTION
Nationwide.
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PRODUCT
a) Pursuit ureteral dilation balloon catheters, 6 mm x 4
cm. Order # PAB-050080-6-4.0. Recall # Z0554-3;
b) Pursuit ureteral dilation balloon catheters, 6 mm x 8
cm. Order # PAB-050080-6-8.0. Recall # Z-0555-03.
CODE
a) Lot 1049345;
b) Lot 1050160.
RECALLING FIRM/MANUFACTURER
Cook Urological, Inc., Spencer, IN, by telephone and letter beginning on January 22, 2003. Firm initiated recall is ongoing.
REASON
Product is labeled sterile, but was not sterilized.
VOLUME OF PRODUCT IN COMMERCE
24.
DISTRIBUTION
Ak, MN, OH, TN, Hawaii, and Ireland.
END OF ENFORCEMENT REPORT FOR FEBRUARY 26, 2003
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