Drug Enforcement D-0154-2025

Failed Impurities/Degradation Specifications

Status

Ongoing

Classification

Class II

Report Date

December 25, 2024

Termination Date

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Product Information

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.
Product quantity
15,744 30-count bottles
Reason for recall
Failed Impurities/Degradation Specifications
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Macleods Pharmaceuticals Ltd
Address
304 Atlanta Arcade, Church Road

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0154-2025
Event ID
95838
Recall initiation date
November 25, 2024
Center classification date
December 19, 2024
Code info
Lot# BOB12318A Exp 07/31/2027
More code info
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