FDA DrugClass IINotable
FDA Recall: Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for:
Description
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Hazard
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Remedy
1200 bottles
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