April 2020 FDA Recall Memantine Hydrochloride by The Harvard Drug Group
D-1262-2020 - Failed dissolution specifications

This Class III drug recall was voluntarily initiated by The Harvard Drug Group on April 24, 2020 for the product Memantine Hydrochloride. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in AL, FL, IA, NY, OH, TX and the recall is currently terminated.

Recall Number: D-1262-2020

Reason for Recall
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Initiated
04-24-2020
Reported
05-20-2020
Quantity
678 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85566
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Harvard Drug Group
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AL, FL, IA, NY, OH, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-19-2022
Product Description About Product Description
Full technical description of the product.
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61

Batch or Lot Expiration Information

Lot# : M02199D, M02246D, Exp 5/2020

Affected Packages Involved in this Recall

0904-6734-61 Memantine Hydrochloride
0904-6736-61 Memantine Hydrochloride
0904-6737-61 Memantine Hydrochloride
0904-6735-61 Memantine Hydrochloride