FDAClass IIFebruary 19, 2020

Memantine Hydrochloride Extended Release Capsules recall: Failed Dissolution

Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland…

Why was Memantine Hydrochloride Extended Release Capsules recalled?

Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: H900330, exp. date 11/2020.

Product
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
6,294 bottles
Distribution
Nationwide within the United States.
Recall date
February 19, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls