Warning
The Harvard Drug Group LLC Recalls Memantine Hydrochloride Extended-Release
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0485-2026Drug / Pharmaceutical
The Harvard Drug Group LLC Recalls Memantine Hydrochloride Extended-Release
The Harvard Drug Group LLC · Class II — Moderate Risk
Product Description
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
Reason for Recall
Failed Dissolution Specifications
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database