Class II
Ongoing
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.
This recall is currently active, issued December 25, 2024. It was issued by Macleods Pharmaceuticals Ltd.
- Company
- Macleods Pharmaceuticals Ltd
- Recall Initiated
- November 25, 2024
- Posted
- December 25, 2024
- Recall Number
- D-0154-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 15,744 30-count bottles
- Firm Location
- Mumbai, India
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide in the USA
Lot / Code Info
Lot# BOB12318A Exp 07/31/2027
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