Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, ...
FDA Recall #D-0154-2025 — Class II — November 25, 2024
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
Recalling Firm
Macleods Pharmaceuticals Ltd — Mumbai
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
15,744 30-count bottles
Distribution
Nationwide in the USA
Code Information
Lot# BOB12318A Exp 07/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated