December 2019 FDA Recall Memantine Hydrochloride by Lupin Pharmaceuticals Inc.
D-0629-2020 - Failed Dissolution Specifications

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on December 10, 2019 for the product Memantine Hydrochloride. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0629-2020

Reason for Recall
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Initiated
12-10-2019
Reported
12-25-2019
Quantity
3,726 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84463
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.
Lupin Pharmaceuticals Inc.
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-29-2021
Product Description About Product Description
Full technical description of the product.
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA

Batch or Lot Expiration Information

Lot# : H901787, H901788, Exp March 2021

Affected Packages Involved in this Recall

68180-246-06 Memantine Hydrochloride
68180-249-06 Memantine Hydrochloride
68180-249-09 Memantine Hydrochloride
68180-249-02 Memantine Hydrochloride
68180-247-06 Memantine Hydrochloride
68180-247-09 Memantine Hydrochloride
68180-248-06 Memantine Hydrochloride