Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.
Reason
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Classification
Class III
Status
Ongoing
Lot
Lot: BOB22321A, Exp 07-31-2027.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Macleods Pharmaceuticals Limited — Class III Recall | MedicineWatch US