drugs Class II Updated 2013-02-06

Schering-Plough Products, LLC recalls Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsule

Recalled Product

Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033

Hazard / Issue

Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: 0NCW005, Exp 02/2013
View official government recall

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