Drug Enforcement D-0183-2025

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

Status

Ongoing

Classification

Class III

Report Date

January 15, 2025

Termination Date

Product Information

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
Product quantity
2591 100-count boxes
Reason for recall
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
US Nationwide.

Location & Firm

Recalling firm
West-Ward Columbus Inc
Address
1809 Wilson Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0183-2025
Event ID
95999
Recall initiation date
December 19, 2024
Center classification date
January 3, 2025
Code info
Lot # AC2556A; Exp. 03/2027
More code info