FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

May 21, 2003
03-21

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

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PRODUCT
Imported Havarti cheese packaged in random-weight 7-10 oz. packages under the following brands:
1. Danish Garden Imported 60% Danish Havarti Cheese;
2. Prima Della Imported 60% Danish Havarti Cheese;
3. Schnucks Danish Havarti. Recall # F-351-3.
CODE
Sell-by dates of November l, 2002 through February 18 and March 12, 2003.
RECALLING FIRM/MANUFACTURER
Swiss American Importing, St Louis, MO, by press releases dated November 21, 2002 and December 3, 2002. State initiated recall is complete.
REASON
Cheese may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
52,998.29 lbs.
DISTRIBUTION
Nationwide.

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PRODUCT
Food Club brand Tartar Sauce, 8 fl. Oz. glass jars, UPC 0-36800-18438-1. Recall # F-357-3.
CODE
The following represents all lot numbers currently within shelf life: 20030226R1; 20030210R1; 20021216R1; 20021114R1; 20021105R1; 20021025R1; 20020924R1; 20020907R1; 20020805R1; 20020703R1; 20020702R1; 20020307R1; 20020224R1.
RECALLING FIRM/MANUFACTURER
The Carriage House Companies, Inc., Fredonia, NY, by fax on March 19, 2003. Firm initiated recall is ongoing.
REASON
The product contains undeclared egg yolks.
VOLUME OF PRODUCT IN COMMERCE
5,155 cases x 12 jars.
DISTRIBUTION
Nationwide.

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PRODUCT
Fancy Candy Platter, 28 oz. There are two known product labels. Both with different ingredient statements.
1) "ING: Milk chocolate covered raisins, rainbow non
pareils, chocolate pretzels, juju fish, yogurt pretzels, super sour worms";
2) "ING: Rainbow non pereils, chocolate covered peanuts,
chocolate pretzels, juju fish, yogurt pretzels, super
sour worms." Recall # F-358-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
J & D Fine Foods, Brooklyn, NY, by E-mail notifications on March 14, 2003 and March 17, 2003. Firm initiated recall is complete.
REASON
Candy platters contained undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
160 cases x 12 per case.
DISTRIBUTION
MA, CT, RI, and NY.

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PRODUCT
Market Basket brand Brownie Fudge Ice Cream in half-gallon containters. Recall # F-372-3.
CODE
Code Date: 12/04/03 0905.
RECALLING FIRM/MANUFACTURER
H. P. Hood, Inc., Chelsea, MA, by fax and email on March 12, 2003. Firm initiated recall is complete.
REASON
The product contained undeclared eggs. VOLUME OF PRODUCT IN COMMERCE
1,275 cases.
DISTRIBUTION
MA, and NH.

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PRODUCT
Chinese Herb Soup packaged in a flexible plastic bag, Net Cont. 78 (+/-5). Recall # F-373-3.
CODE
2000.11.20.
RECALLING FIRM/MANUFACTURER
Mon Chong Loong Trading Corp., Maspeth, NY, by press release on July 27, 2001 and telephone on July 21, 2001. State initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
NY.

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PRODUCT
Rose brand Raison Golden (Golden Raisins) packed in plastic bags, Net Wt. 7 oz. Recall # F-374-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Best Foods, Inc., Maspeth, NY, by a Food Safety Alert, and letter on August 22, 2002. State initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
5 cases (24 - 7 oz. packages per case).
DISTRIBUTION
NY, and FL.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

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PRODUCT
a) Dried smoked catfish steaks packed in flexible plastic
bags. The product does not bear a statement of
identification or weight, only the manufacturer is
identified on the label. Recall # F-349-3;
b) Dried smoked catfish whole fish packed in flexible
plastic bags. The product does not bear a statement of
identification or weight, only the manufacturer is
identified on the label. Recall # F-350-3.
CODE
All products shipped between August 24 - September 8, 2002 are subject to recall.
RECALLING FIRM/MANUFACTURER
Hope African Food Line & Seafood Supply, by telephone on October 3, 2002, and by letter dated December 16, 2002. FDA initiated recall is ongoing.
REASON
The firm violated its Consent Decree of Permanent Injunction by continuing to ship dried smoked catfish products to consumers after August 23, 2002.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,500 lbs.
DISTRIBUTION
IL, MD, TX, GA, FL, TN, MN, CO, NJ, and CA.

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PRODUCT
Guacamole Dip, packaged in 6.5 oz cups (12 per case) and 16 oz cups (6 per case), labeled under the Lucerne (6.5 oz), Lakeview (6.5 oz and 16 oz), and Bashas (16 oz) brand names. The products are to be refrigerated.
Recall # F-356-3.
CODE
All lots on the market at the time the recall was initiated. Catalog/Item numbers: 001622 (Lucerne, 6.5 oz), 001623 (Lakeview, 6.5 oz), 001624 (Bashas, 16 oz), and 001625 (Lakeview, 16 oz).
RECALLING FIRM/MANUFACTURER
Lakeview Farms, Inc., Delphos, OH, by telephone, fax, and mail beginning on March 13, 2003. FDA initiated recall is ongoing.
REASON
The product contains undeclared color, FD&C Yellow #6.
VOLUME OF PRODUCT IN COMMERCE
10,298 cases (64,908 units).
DISTRIBUTION
CA, AZ, PA, IL, IA, TX, and UT.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

________________________________
PRODUCT
Botanas Mexico's Best Snacks brand "Botana Fiesta" (Assorted Snacks Spicy), Net Wt. 2 oz. Recall # F-368-3.
CODE
None.
RECALLING FIRM/MANUFACTURER
La Mexican Enterprises, Inc., Corona, NY, by press release on February 27,2001. State initiated recall is complete.
REASON
The product, consisting mainly of shelled peanuts, does not bear an ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
Firm operates on a cash and carry basis so no records are available.

________________________________
PRODUCT
THERMO-TEK Capsules, Product number 01-100, packaged in 250 cc red plastic bottles with black ribbed plastic caps, 120 capsules per bottle. Product was labeled in part, "*** IRON-TEK *** Advanced Performance Nutrition *** ADVANCED FAT LOSS CATALYST *** Now Contains: Yohimbine and Theophylline *** THERMO-TEK *** 120 CAPSULES *** Dietary Supplement *** IRON-TEK ADVANCED PERFORMANCE NUTRITION ***. Recall # F-376-3.
CODE
All codes of IRON-TEK brand Thermo-Tek Capsules packaged
in red plastic bottles - specifically codes 2419, 2317, and other codes distributed before January 2001 which had been contract manufactured by Horizon for IRON-TEK.
RECALLING FIRM/MANUFACTURER
Recalling Firm: IRON-TEK Advanced Nutrition, Inc. Hauppauge, NY, by faxed letters dated November 30, 2001, and by mail on December 12, 2001.
Manufacturer: Horizon Pharmaceuticals Inc., St. Petersburg, FL. FDA initiated recall is complete.
REASON
The dietary supplement contained a smaller amount of theophylline than listed on the label.
VOLUME OF PRODUCT IN COMMERCE
6,580 bottles
DISTRIBUTION
Nationwide, the West Indies, and West Africa.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
Nicotine Polacrilex Gum USP, 4 mg (Active ingredient (in each piece) 4 mg nicotine), STARTER KITS (each carton contains 108 Chewing Pieces in blister packs) and REFILL KITS (each carton contains 48 Chewing Pieces in blister packs)--- Distributed under the following private labeling: ----CVS pharmacy brand, POLACRILEX GUM USP, NICOTINE 4 mg, ORIGINAL, ---- Rugby brand, nicotine polacrilex gum, USP, 4 mg (nicotine, ---- Walgreens brand, Nicotine Gum 4 mg, nicotine polacrilex, USP, --- LEADER brand, Nicotine Gum, Nicotine Polacrilex Gum USP, 4 mg (nicotine).
Recall # D-225-3.
CODE
Lot numbers: 4NG02021-Exp Date 07/01/2004;
4NL02133-Exp Date 11/01/2004.
RECALLING FIRM/MANUFACTURER
Watson Diagnostics, Inc., Corona, CA, by letter dated April 7, 2003. Firm initiated recall is ongoing.
REASON
Contamination: pieces of latex gloves were found in the gum.
VOLUME OF PRODUCT IN COMMERCE
19,853 cartons (total for both lots).
DISTRIBUTION
Nationwide.

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PRODUCT
Oxygen Compressed USP, E cylinders. Recall # D-235-3.
CODE
Lot V01Q007B.
RECALLING FIRM/MANUFACTURER
Hammer Medical Supply, Inc., Des Moines, IA, by telephone on January 24, 2003. Firm initiated recall is complete.
REASON
A portion of the lot was released as unfilled cylinders by the contract manufacturer (Airgas-North Central).
VOLUME OF PRODUCT IN COMMERCE
35 cylinders.
DISTRIBUTION
IA.

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PRODUCT
Bite Out, cream hydrocortisone, 1 %, 1 oz jars, Made in the U.S.A. Exclusively for: Tangled Vine, Shell Knob, MO. Recall # D-236-3.
CODE
Lot # 3940 MFD 07/02.
RECALLING FIRM/MANUFACTURER
Vita-Erb Ltd., Springfield, MO, by letter dated March 12, 2003. Firm initiated recall is complete.
REASON
Subpotency and failure to manufacturer product under Good Manufacturing Practice Regulations.
VOLUME OF PRODUCT IN COMMERCE
78/1 oz. jars.
DISTRIBUTION
MO.

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PRODUCT
Pro Pam, Liquid, Pinworm Treatment, Pyrantel Pamoate base 50mg/ml, 2, 8, 16, and 32 fl. Oz. containers.
Recall # D-237-3.
CODE
Lot numbers 7501 through 7519.
RECALLING FIRM/MANUFACTURER
Protec Laboratory, Division of SSB Holdings, Inc, Belton, TX, by letter on June 6, 2001. Firm initiated recall is complete.
REASON
Failure to manufacture under Good Manufacturing Practices including, but not limited to, lack of batch production records.
VOLUME OF PRODUCT IN COMMERCE
503 gallons.
DISTRIBUTION
TX.

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PRODUCT
a) Levothroid Tablets (levothyroxine sodium tablets, USP),
25 mcg., 100-tablet bottles, FOREST, Rx Only.
Recall # D-238-3;
b) Levothroid Tablets (levothyroxine sodium tablets, USP),
175 mcg., 100-tablet bottles, FOREST, Rx Only.
Recall # D-239-3;
CODE
a) Lot 40245, Exp 05/2004;
b) Lot 5023, Exp. 05/2004;
Lot 5024, Exp. 05/2004.
RECALLING FIRM/MANUFACTURER
Forest Pharmaceuticals, Inc., Earth City, MO, by letters on April 1, 2003. Firm initiated recall is ongoing.
REASON
Contamination; tablets contain trace levels of the solvent isophorone.
VOLUME OF PRODUCT IN COMMERCE
a) 14,131 bottles;
b) Lot 5023 - 12,398 bottles;
Lot 5024 - 9,192 bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
a) Liposyn II 10%, Intravenous Fat Emulsion, 500 mL single
dose containers, Rx only. Recall # D-241-3;
b) Liposyn II 20%, Intravenous Fat Emulsion, 200 mL and 500
mL single dose containers, Rx only, Recall # D-242-3;
c) Liposyn III 10%, Intravenous Fat Emulsion, 500 mL single
dose containers, Rx only. Recall # D-243-3;
d) Liposyn III 20% Intravenous Fat Emulsion, 500 mL single
dose containers, Rx only. Recall # D-244-3;
e) Liposyn III 30%, Intravenous Fat Emulsion, 500 mL single
dose glass bottle, Rx only, Pharmacy Bulk Package, Not
for Direct Infusion Recall # D-245-3;
f) Propofol Abbott Injection, 10 mg/mL, 20mL, 50mL, 100mL
vials and 20 mL Ampoules, Emulsion for IV Injection or
Infusion Sterile, Abbott Laboratories, North Chicago, IL
60064 Also sold as: Propofol Injection, 200mg/20mL,
Abbott Australasia PTY LYD, Kurnell 2231 Australia,
Abbott Laboratories (NZ) LTD, Naenae Lower Hutt New
Zealand Propofol Emulsion Inyectable I.V., 10 mg/mL,
500mg en 50 mL vial, Manufacturado por: Abbott
Laboratories, North Chicago, IL 60064, USA Propofol
Injection/Injectable, Abbott Laboratories Limited,
Laboratoires Abbott Limitee, Saint-Laurent, Qc H4S 1Z1
Propocam, Propofol.Emulsion Inyectable, 200mg, Fabricado
en Estados Unidos por: Abbott Laboratories North
Chicago, IL, Acondicionado y distribuido en Mexico por;
Abbott Laboratories de Mexico SA de CV Av Coyoacan No
1622, Col del Valle CP 03100, Mexico Propofol
Medicamento Generico Lei, 10 mg/ml, 5 frascos-ampola de
20 ml, Abbott Laboratories do Brasil Ltda PropoFlo,
propofol Ph Eur 10 mg/ml, 20 ml vials, injectable
anaesthetic for dogs and cats, Manufactured for: Abbott
Laboratories, Queenborough, Kent ME11 5EL, By Abbott
Laboratories, North Chicago, IL. Recall # D-246-3.
CODE
a) Lot 85396DE;
b) Lots 85394DE; 85393DE (200mL); Lots 84363DE, 84364DE,
85385DE, 85390DE, 85400DE, 84362DE, 85399DE (500mL).
c) Lot 85389DE;
d) Lots 84365DE, 84374DE, 84378DE, 85384DE, 85387DE,
85388DE, 85397DE, 85398DE, 85401DE;
e) Lot 84381DE;
f) Lots 84850Z7, 85718Z7, 84851Z7, 84839X7, 85712Z7,
85715Z7, 85726Z7, 84843Z7, 85711Z7, 85714Z7, 85717Z7,
84849Z7, 84842Z7, 85710Z7, 85724Z7, 85725Z7, 84841Z7,
84959Z7 (vet product).
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated March 31, 2003. Firm initiated recall is ongoing.
REASON
Contaminated, product contains stainless steel particles.
VOLUME OF PRODUCT IN COMMERCE
157,164 bottles; 449,520 vials.
DISTRIBUTION
Nationwide, and Canada, Singapore, Thailand, Turkey, Lithuania, Bosnia, Pakistan, Australia, Mexico, Malaysia, Hong Kong, Malta, Croatia, Bulgaria, Brazil, England, Italy. Please Note: The Propofol products were not distributed in the US.

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PRODUCT
Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 300mcg, 100 and 1,000 tablet bottles, J P Jones, Rx only. Recall # D-248-3.
CODE
300 mcg, 100 tablet bottle: Lot Nos.: 7325 (Exp date 07/03), 7483 (09/03), 7484 (09/03), 7776 (01/04) 300 mcg, 1,000 tablet bottles: Lot Nos. 7325 (Exp date 7/03), 7484 (9/03), 7775 (1/04).
RECALLING FIRM/MANUFACTURER
King Pharmaceuticals, Inc., Bristol, TN, by letter dated April 16, 2003. Firm initiated recall is ongoing.
REASON
Subpotency; during stability testing.
VOLUME OF PRODUCT IN COMMERCE
84,844 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
Senokot-S Tablets (Docusate sodium 50mg and Sennosides 8.6mg) Natural Vegetable Laxative plus Softener, Standardized Senna Concentrate and Docusate Sodium, blisterpack of 4 tablets, Professional Samples: Not for Sale. Recall # D-224-3.
CODE
Lot JV31, Exp. 01/04;
Lot JV41, Exp. 01/04;
Lot MA11, Exp. 06/04.
RECALLING FIRM/MANUFACTURER
The Purdue Frederick Company, Stamford, CT, via voicemail on March 11, 2003, and follow-up letter on March 21, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled; Labeling does not indicate dosage instructions for children under 2 years of age.
VOLUME OF PRODUCT IN COMMERCE
924,279.
DISTRIBUTION
Nationwide.

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PRODUCT
Liquid Oxygen USP, 45 liter in home cryogenic vessels.
Recall # D-226-3.
CODE
Serial numbers (vessels): 6089918017, 590001035, 599720020, 599726024, 599725054, 599640003, 599640005, 590001037, 599725060, 599911021, 599950056, 599640004, 599719023, 599739086, 599640002, 599720119, 590136019, 599738091, 599950004, 590136016, 599720116, 599726026.
RECALLING FIRM/MANUFACTURER
Olympic Pharmacy & Healthcare, Gig Harbor, WA, by telephone on March 26, 2003. Firm initiated recall is ongoing.
REASON
GMP deviations, including but not limited to, failure to maintain records of testing for purity, strength, and identity.
VOLUME OF PRODUCT IN COMMERCE
22 vessels.
DISTRIBUTION
WA.

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PRODUCT
a) Fiber Tabs (Calcium polycarbophil) 625mg equivalent to
500mg polycarbophil, 250 caplet count bottles, Bulk-
Forming Fiber Laxative, Kirkland Signature brand.
Recall # D-230-3;
b) Fiber Caplets (Calcium polycarbophil) 625mg equivalent
to 500mg polycarbophil, 250 caplet count bottles, Bulk-
Forming Fiber Laxative Recall #D-231-3;
c) Fiber Lax Caplets (Calcium polycarbophil) 625mg
equivalent to 500mg polycarbophil, 90 count bottles,
Bulk-Forming Fiber Laxative. Recall #D-232-3.
CODE
a) Lot number 2HA0654;
b) Lot numbers: 2HA0768, 2HA0905 and 2HA0651;
c) Lot number: 2HA0652.
RECALLING FIRM/MANUFACTURER
Leiner Health Products, Carson, CA, by letters on March 31, 2003. Firm initiated recall is ongoing.
REASON
Tablet mixup; bottles may contain acetaminophen tablets (500mg).
VOLUME OF PRODUCT IN COMMERCE
15,454 bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
Methocarbamol Tablets USP, 500 mg, 100 and 500 tablet bottles, Watson, Rx Only. Recall # D-240-3.
CODE
a) C2L1076, Exp. 12/31/2004;
b) C2K1014, Exp. 12/31/2004.
RECALLING FIRM/MANUFACTURER
Watson Pharmaceuticals, Inc., Corona, CA, by letters dated April 15, 2003. Firm initiated recall is ongoing.
REASON
Dissolution Failure; 3 month stability sample.
VOLUME OF PRODUCT IN COMMERCE
a) 1,960 bottles;
b) 21,643 bottles
DISTRIBUTION
Nationwide.

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PRODUCT
Enalapril Maleate Tablets, USP, 10 mg, bottles of 1000, TEVA, Rx only. Recall # D-247-3.
CODE
Lot # 15741 exp 5/31/03.
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, North Wales, PA, by letters dated March 19, 2003. Firm initiated recall is ongoing.
REASON
Degradation: Related compound specification failure (18 month stability).
VOLUME OF PRODUCT IN COMMERCE
1,182 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
a) Platelets Pheresis Leukocytes Reduced.
Recall # B-0966-3;
b) Platelets Pheresis Leukocytes Reduced Irradiated.
Recall # B-0967-3;
CODE
a) Unit number 21KP33410;
b) Unit number 21KP34490.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter on June 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OR.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0968-3.
CODE
Unit number 21KP28086.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter on May 2, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0969-3;
b) Recovered Plasma. Recall # B-0970-3.
CODE
a) and b) Unit number 21GE19877.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter on March 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to medication with the drug Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WA, and CA.

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PRODUCT
a) Plasma. Recall # B-0971-3;
b) Recovered Plasma. Recall # B-0972-3.
CODE
a) Unit number 21KM34985;
b) Unit numbers 21KM31477 and 21KM21942.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on March 28, 2002, and by letter on April 1 and 2, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OR, and CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0973-3.
CODE
Unit number 70473445.
RECALLING FIRM/MANUFACTURER
Nabi, Scranton, PA, by letter on October 4, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Human Tissues for Transplantation Corneas.
Recall # B-0974-3;
CODE
Serial # 2003-03-6057.
RECALLING FIRM/MANUFACTURER
Heartland Lions Eye Bank, Columbia, MO, by telephone and letter on April 15, 2003. Firm initiated recall is complete.
REASON
Human cornea, collected from a donor with discordant Hepatitis B Virus test result, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MO.

_______________________________
PRODUCT
Source Plasma. Recall # B-0975-3.
CODE
Unit number 70491463 and 70493177.
RECALLING FIRM/MANUFACTURER
Nabi, Scranton, PA, by letter on August 5, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0976-3.
CODE
Unit number 70481266, 70483093, 70484540, 70486667, and 70488449.
RECALLING FIRM/MANUFACTURER
Nabi, Scranton, PA, by letter on August 5, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0977-3;
b) Cryoprecipitated AHF. Recall # B-0978-3.
CODE
a) and b) Unit number 21KZ03364.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on October 4, 2001, and by letter on October 10, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WA, and CA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0979-3;
b) Platelets. Recall # B-0980-3;
c) Fresh Frozen Plasma. Recall # B-0981-3.
CODE
a), b), and c) Unit number 0596224.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter on March 19, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose body temperature was not determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated.
Recall # B-0983-3.
CODE
Unit number 0833444 (distributed as 2 split products).
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone on July 2, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to recent ingestion of aspirin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0984-3.
CODE
Unit number 01Y43255.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letter on August 19, 2002.
Manufacturer: American Red Cross Blood Services, Fairport, NY. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0985-3.
CODE
Unit number 01FF47133.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by facsimile on August 26, 2002.
Manufacturer: American Red Cross Blood Services, Binghamton, NY. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
______________________________
PRODUCT
Portable HDX Dental X-Ray System. Recall # Z-1272-02.
CODE
All Portable HDX Systems manufactured and distributed from August 2000 through July 2002 are included in this CAP.
RECALLING FIRM/MANUFACTURER
DentalEZ (StarDental), Lancaster, PA, by service representative starting in May 2003. Firm initiated recall is ongoing.
REASON
The Portable HDX Intraoral Dental X-Ray Systems contained a noncompliant date format on the labels and the serial number and date on the labels of were not legible.
VOLUME OF PRODUCT IN COMMERCE
231 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Sedecal X-Ray High Voltage Generators and Controls.
Recall # Z-0649-03.
CODE
Model SHF210, serial numbers G13360, G13782, G13810, G13812, G13814, G13815; Model SHF310, serial numbers G13058, G13269, G13335, G13336, G13361, G13364, G13367, G13430, G13536, G13441, G13442, G13550, G13553, G13577, G13587, G13591, G13595, G13605, G13648, G13651, G13653, G13656, G13790, G13800, G13822, G13854, G13855, G13856, G13868, G13930, G13932, G14023, G14029, G14032, G14034, G14035, G14037, G14038, G14039, G14321, G14325, G14326, G14328, G14332, G14391, G14394, G14558, G14576, G14577, G14581, G14584, G14585, G14675, G14727, G14731, G14734, G14736, G14737, G14738, G14740, G14767, G14768, G14780, G14781, G14782, G14785, G14786, G14820, G14821, G14794, G14795, G14796, G14798, G14800, G14837, G14850, G14873, G14874, G14989; Model SHF310RF, serial numbers G13404, G13547; Model SHF310LS, serial numbers G13405, G13429, G14354; Model SHF310AEC, serial number G14028; Model SHF310PSU, serial numbers G14359, G14569, G14607; Model SHF315, serial number G14926; Model SHF320, serial numbers G13314, G13437, G13453, G13467, G13476, G13483, G13491, G13524, G13525, G13544, G13551, G13556, G13558, G13560, G13563, G13718, G13722, G13738, G13739, G13806, G13809, G13813, G13816, G13823, G13944, G13946, G13956, G13957, G14271, G14274, G14367, G14762, G14763, G14829, G15019, G15023; Model SHF320F, serial number G13270; Model SHF320RF, serial numbers G14016, G14019, G14027; Model SHF320CE, serial numbers G14453, G14455, G14847, G14853; Model SHF320LS, serial number G14051; Model SHF330, serial numbers G13303, G14171, G14249, G14324, G14343, G14969; Model SHF410, serial numbers G13357, G13537, G13992, G14037, G14053, G14313, G14328, G14813; Model SHF410RF, serial number G14538; Model SHF420, serial numbers G13760, G14013, G14269, G14329; Model SHF420RF, serial numbers G14047, G14621, G14885; Model SHF430RF, serial number G14620; Model SHF510, serial numbers G14490, G14529, G14668, G14876, G14904; Model SHF510LS, serial numbers G14167, G14169; Model SHF520, serial numbers G13527, G13581, G13704, G14210, G14317; Model SHF520RF, serial numbers G14317, G14669, G14881; Model SHF520LS, serial number G13918; Model SHF525RF, serial numbers G14248, G13251; Model SHF530, serial number G13574; Model SHF530LS, serial number G14728; Model SHF535, serial numbers G13233, G13273, G14869, G14869; Model SHF625, serial number G13378; Model SHF630, serial numbers G13230, G14345, G14670, G14971; Model SHF630RF, serial numbers G14392, G14747; Model SHF635, serial number G14395; Model SHF835, serial numbers G13724, G14507; Model SHF835RF, serial numbers G13240, G13240.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sedecal USA, Inc., Arlington Heights, IL, by letters dated September 26, 2002.
Manufacturer: SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN. FDA initiated recall is ongoing.
REASON
Incorrect identification labels and their certification testing program failed in noncompliance with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE
199 units.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
Easy Moving Motor Driven Mobile X-Ray Unit,
a) Model SM-20HF. Recall # -650-03;
b) Model SM-30HF. Recall # Z-651-03.
CODE
a) Model SM-20HF, serial numbers G13487, G13457;
b) Model SM-30HF, serial numbers G12468, G13449,
G13540, G13747, G13765, G14097, G14099, G14633, G15025.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sedecal USA, Inc., Arlington Heights, IL, by letters dated September 26, 2002.
Manufacturer: SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN. FDA initiated recall is ongoing.
REASON
Incorrect identification labels and failure of the certification testing resulting in noncompliance with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
NC, LA, NY, NJ, MO, KY, TX, and Germany.
______________________________
PRODUCT
Optima URS X-Ray System. Recall # Z-0652-03.
CODE
Serial numbers G14698, G14689, G14501, G14932, and G14835.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sedecal USA. Inc., Arlington Heights, IL, by letters dated September 24, 2002.
Manufacturer: SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN. FDA initiated recall is ongoing.
REASON
Incorrect identification labels and their dertification testing program failed in noncompliance with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NY, TX, FL, and MN.
______________________________
PRODUCT
Halo Support Bracket Assembly (Part # 438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component. The defective sub-assembly part is the Clamp Assembly (Part #438A1071), which is part of the Halo Bracket Assembly. Recall # Z-0781-03.
CODE
Lot # 031 - etched on the side of the Clamp Assembly.
RECALLING FIRM/MANUFACTURER
Ohio Medical Instrument Co, Inc., Cincinnati, OH, by email and telephone on February 26, 2003. Firm initiated recall is ongoing.
REASON
The component was manufactured with an insufficient weld that could break during use.
VOLUME OF PRODUCT IN COMMERCE
32 components.
DISTRIBUTION
NY, NJ, IL, FL, Japan, Hong Kong, Korea, Great Britain, and Germany.
______________________________
PRODUCT
Architect Progesterone Reagent Kit:
a) List 6C26-27 (100 tests);
b) List 6C26-22 (400 tests). Recall # Z-0782-03.
CODE
a) Lot 95651M201;
b) Lots 95651M200, 95651M202.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by telephone and letters on March 31, 2003. Firm initiated recall is ongoing.
REASON
Lot gives lower specimen results compared to results generated with other lots.
VOLUME OF PRODUCT IN COMMERCE
368 kits.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
a) MAC-LAB 1000EX systems. Recall # Z-0783-03.
b) MAC-LAB 3000EX systems. Recall # Z-0784-03.
c) MAC-LAB 5000EX systems. Recall # Z-0785-03;
d) MAC-LAB (Classic) systems. Recall # Z-0786-03;
CODE
The affected systems have serial numbers with XC and 4A as 3rd and 4th characters in the serial number.
RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letter on April 14, 2003. Firm initiated recall is ongoing.
REASON
There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.
VOLUME OF PRODUCT IN COMMERCE
1,330 devices.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01. Recall #Z-0788-03.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on February 24, 2003. Firm initiated recall is ongoing.
REASON
Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.
VOLUME OF PRODUCT IN COMMERCE
645 units.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
Vicks brand Warm Mist Humidifier, Model V610, "Pure warm moisturizer for soothing relief of cold and flu symptoms" sold over the counter. Recall #Z-0790-03.
CODE
8-digit code ending in either 2KUO or 3KUO.
RECALLING FIRM/MANUFACTURER
KAZ, Inc, Hudson, NY, by letters dated April 16, 2003. Firm initiated recall is ongoing.
REASON
Humidifiers may overheat.
VOLUME OF PRODUCT IN COMMERCE
110,000 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Phillips ADAC brand C-PET and Allegro Imaging Systems. Recall # Z-0811-03.
CODE
DICOM 3.0, C-PET rev. 7.3.5: SW-CD-UGM-7.3.5 rev. 1;
DICOM 3.0, Allegro rev. 8.0.1: SW-CD-UGM-8.0.1rev. 0.
RECALLING FIRM/MANUFACTURER
Phillips ADAC Milpitas, CA, by letters on July 24, 2002. Firm initiated recall is complete.
REASON
Resulting images may be labeled incorrectly on PETView and receiving system.
VOLUME OF PRODUCT IN COMMERCE
104.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS I

_________________________
PRODUCT
Piggy Rope Bone, 5", 7", and 9". Piggy Rope Bone packaged 5" and 7". Piggy Rope Bones, 4 pk 7". Recall # V-041-3.
CODE
Item #s: 7595, 7585, 7587, 7589, 7597, 7582, and 7599.
RECALLING FIRM/MANUFACTURER
Petrapport, Carlstadt, NJ, by letters on March 3, 2003. FDA initiated recall is ongoing.
REASON
Piggy Rope Bone was found to contain Salmonella.
VOLUME OF PRODUCT IN COMMERCE
36,746.
DISTRIBUTION
Nationwide, and Canada.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________
PRODUCT
Consolidated Nutrition 32 % Floating Catfish Food, packaged in 50-lb bags. Recall # V-100-3.
CODE
Best By MAR 25 04; and Best By APR 16 04, The codes are ink-jetted on the bags.
RECALLING FIRM/MANUFACTURER
Doane Pet Care Company, Inc., Washington Courthouse, OH, by telephone and letter on April 16, 2003 and April 17, 2003. FDA initiated recall is ongoing.
REASON
The fish feed product lacks the required BSE warning statement, and the nutritional ingredient statement on the label.
VOLUME OF PRODUCT IN COMMERCE
210/50 lb bags.
DISTRIBUTION
OH, PA, and MI.

______________________________
PRODUCT
a) Robert Vormezelle CPX 6233-02 Non-Medicated Beef Premix;
mix 0.32 lbs premix into grain/roughage per head per
day; 50 lb. multilayer paper bags. Recall # V-102-3;
b) Bob and Francis Vormezeele Beef Supplement, Medicated;
Monensin Sodium, 333 grams per ton; mix 1.65 lbs
supplement into grain/roughage per head per day; 50 lb.
multilayer paper bags. Recall # V-103-3;
c) Eastland Sow/Starter VTM #6242-02 Non-Medicated
Vitamin-Mineral Premix; 50 lb. multilayer paper bags.
Recall # V-104-3;
d) Gerry Meinsma CPX 6219-06 Beef Grower Premix Medicated
w/Rumensin; Monensin, 1010.4 grams per ton; mix 0.198
lbs premix into grain/roughage per head per day; 50 lb.
multilayer paper bags. Recall # V-105-3;
e) Paul Kane CPX 1595-10 Beef FInisher Premix Medicated
w/Rumensin; Monensin, 1511.2 grams per ton; mix 0.331
lbs premix into grain/roughage per head per day; 50 lb.
multilayer paper bags. Recall # V-106-3.
f) Special Envir-O-Mix 4100-12, non-medicated premix; mix
50 lbs premix per ton finished feed; 50 lb. multilayer
paper bags. Recall # V-107-3;
g) Dacomix 1-S Grower Mineral-Vitamin Premix for Swine;
mix 50 lbs premix per ton finished feed; 50 lb.
multilayer paper bags. Recall # V-108-3;
h) Dacomix 3-S Vitamin-Mineral Premix for Swine; mix 50 lbs
premix per ton finished feed; bulk premix.
Recall # V-109-3;
i) Mac-O-Lac (SE) Mineral-Vitamin Premix for Dairy and Beef
Cattle; mix 0.18 lbs premix into a complete beef or
dairy grain mix per head per day; 50 lb. multilayer
paper bags. Recall # V-110-3.
CODE
a) Product code 6233-02, lot 9342, December 2, 2002;
b) Batch 31396, December 3, 2002;
c) Product code 6242-02, lot 9356, December 4, 2002;
d) Product code 6219-06, lot 9442, January 13, 2003;
e) Product code 1595-10, lot 9428, January 6, 2003;
f) Product code 4100-12, lots 9337, 9338, 9339, 9340,
November 26, 2002;
g) Product code 463, lot 9437, January 10, 2003;
h) Product code 475, lots 9404, 9405, 9406, 9407,
December 26,2002;
i) Product code 675, lot 9378, December 10, 2002.
RECALLING FIRM/MANUFACTURER
Daco Laboratories, Ltd., Forreston, IL, by telephone on April 8-11, 2003. Firm initiated recall is ongoing.
REASON
The 72% Zinc Oxide used in the manufacture of the feeds was contaminated with dioxin.
VOLUME OF PRODUCT IN COMMERCE
44,547 lbs.
DISTRIBUTION
IL.

______________________________
PRODUCT
Synovex Plus (trenbolone acetate and estradiol benzoate), Implants for Steers and Heifers Fed in Confinement for Slaughter, one implant (eight pellets) contains 200 mg. of trenbolone acetate and 28 mg. of estradiol benzoate, packaged in a 10-dose (8 pellets per dose) cartridge, 10 cartridges per foil pouch, 1 pouch per unit carton.
Recall # V-163-3.
CODE
605123, Exp. Jul 03; 605126, Exp. Jul 03; 605127, Exp. Aug 03; 605129, Exp. Aug 03; 605130, Exp. Aug 03; 605131, Exp. Aug 03; 605132, Exp. Sep 03; 605133, Exp. Sep 03; 605134, Exp. Sep 03; 605135, Exp. Sep 03; 605137, Exp. Oct 03; 605138, Exp. Nov 03; 605139, Exp. Nov 03; 605140, Exp. Nov 03; 605141, Exp. Jan 04; 605142, Exp. Jan 04; 605143, Exp. Feb 04; 605144, Exp. Feb 04; 605145, Exp. Apr 04; 605146, Exp. Apr 04; 605147, Exp. Apr 04; 605148, Exp. May 04; 605149, Exp. May 04; 605150, Exp. Jun 04; 605151, Exp. Apr 04; 605152, Exp. Jun 04; 605153, Exp. Jun 04; 605154, Exp. Jul 04; 605155, Exp. Jul 04;605156, Exp. Jul 04; 605161, Exp. Nov 04.
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories, Inc., Fort Dodge, IA, by letters dated October 9, 2002. Firm initiated recall is ongoing.
REASON
Package integrity failure.
VOLUME OF PRODUCT IN COMMERCE
80,993 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS III

______________________________
PRODUCT
Cydectin moxidectin Pour-On for Beef and Dairy Cattle, Antiparasitic, containing 5 mg. Moxidectin/ml, packaged in 1-liter bottles, OTC. Recall # V-111-3.
CODE
Lot #268451, Exp. July, 2003.
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories, Inc., Fort Dodge, IA, by letter dated February 7, 2003. Firm initiated recall is ongoing.
REASON
Stability failure at 30-month test station.
VOLUME OF PRODUCT IN COMMERCE
3,624/1-liter bottles.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR MAY 21, 2003

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