D-0154-2025 Class II Ongoing

Recalled by Macleods Pharmaceuticals Ltd — Mumbai

Recall Details

Product Type
Drugs
Report Date
December 25, 2024
Initiation Date
November 25, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,744 30-count bottles

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot# BOB12318A Exp 07/31/2027