FDAHealthNovember 25, 2024
Macleods Pharmaceuticals Ltd — 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. Pri
⚠️ Failed Impurities/Degradation Specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 25, 2024
Nationwide in the USA
What's affected?
- 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.
- Brand
- OLANZAPINE
- UPC
- 0333342067074
- Lot code
- BOB12318A
Additional details
Lot# BOB12318A Exp 07/31/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 15,744 30-count bottles.
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