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RE: MTX recall

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http://www.safetyalerts.com/recall/f/02/f0001054.htm

SafetyAlerts

July 11, 2002

American Pharmaceutical Partners Has

Recalled Methotrexate For Injection

(SafetyAlerts) - The Food and Drug Administration

(FDA)

has released the following information.

PRODUCT

Methotrexate For Injection USP, 1 g, lyophilized,

preservative free 1 g Single Dose Vial, Sterile, Rx

only,

NDC #63323-122-50. Recall # D-341-2

CODE

Lot numbers: 210275-1, 210305-1, 210315-1, 210276-1,

210306-1, 210303-1,

210308-1, 210326-1, 210323-1.

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Pharmaceutical Partners,

Inc.,

Melrose Park, IL, by letter dated June 11, 2002.

Manufacturer: Bigmar Pharmaceuticals, Bargengo,

Switzerland.

Firm initiated recall is ongoing.

REASON

Misbranding; The product is labeled with the wrong

NDC #

and has a misspelled name.

VOLUME OF PRODUCT IN COMMERCE

29,361 vials.

DISTRIBUTION

Nationwide.

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