February 2020 FDA Recall Memantine Hydrochloride by Lupin Pharmaceuticals Inc.
D-0855-2020 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on February 12, 2020 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-0855-2020
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
02-12-2020
02-19-2020
6,294 bottles
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States.
06-03-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06
Batch or Lot Expiration Information
Lot# : H900330, exp. date 11/2020.
