Product: Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.
Reason for recall: Failed Impurities/Degradation Specifications
Recall initiated: 20241125
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated