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Recall Observatory FDA recall evidence

Drug product

Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India

D-0347-2025

March 13, 2025

Class II

Product summary

Firm
Glenmark Pharmaceuticals Inc., USA
Event
Event 96474
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0347-2025

Official wording

Reason: CGMP Deviations

Code information: Lot # 17241302, exp. date Jul-26 Amazon & Walmart 17241140, exp. date Jul-26 Amazon & Walmart 17241141, exp. date Jul-26 Amazon & Walmart

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations