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Recall Observatory FDA recall evidence

Drug product

Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20

D-0183-2025

December 19, 2024

Class III

Product summary

Firm
West-Ward Columbus Inc
Event
Event 95999
Status
Ongoing
Classification
Class III
Quantity
2591 100-count boxes
Official record key
drug-enforcement:D-0183-2025

Official wording

Reason: Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

Code information: Lot # AC2556A; Exp. 03/2027

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.