Memantine Hydrochloride Extended-release Capsules recall: Failed Dissolution
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
Why was Memantine Hydrochloride Extended-release Capsules recalled?
Failed Dissolution Specifications: High out of specification result observed at stability studies.
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 #: H901787, H901788, Exp March 2021
- 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
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 3,726 bottles
- Distribution
- Nationwide in the USA
- Recall date
- December 25, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)