Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikm...
FDA Recall #D-0183-2025 — Class III — December 19, 2024
Product Description
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
Reason for Recall
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Recalling Firm
West-Ward Columbus Inc — Columbus, OH
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
2591 100-count boxes
Distribution
US Nationwide.
Code Information
Lot # AC2556A; Exp. 03/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated