Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA I
Summary
The FDA issued a Class III for Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Dis by West-Ward Columbus Inc. Reason: Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only..
Details
Source
Drug Recall
External ID
D-0183-2025
Action Date
2025-01-15
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot # AC2556A; Exp. 03/2027
Quantity Affected: 2591 100-count boxes
Reason for Recall
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-19
Company
Columbus, OH
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
West-Ward Columbus Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (West-Ward Columbus Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does West-Ward Columbus Inc have FDA actions?
West-Ward Columbus Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0183-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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