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.
Recall Number: D-0867-2026
Firm: Macleods Pharmaceuticals Limited
Classification: Class III
Status: Ongoing
Report Date: 20260930
Initiation Date: 20260827
Termination Date:
Reason for Recall
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Product Description
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.