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.
Reported: December 25, 2024 Initiated: November 25, 2024 #D-0154-2025
Product Description
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
Details
- Recalling Firm
- Macleods Pharmaceuticals Ltd
- Units Affected
- 15,744 30-count bottles
- Distribution
- Nationwide in the USA
- Location
- Mumbai
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Macleods Pharmaceuticals Ltd. Units affected: 15,744 30-count bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 25, 2024. Severity: Moderate. Recall number: D-0154-2025.
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