Memantine Hydrochloride Extended-Release Capsules recall: Failed Dissolution
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
Why was Memantine Hydrochloride Extended-Release Capsules recalled?
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
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 #: M02199D, M02246D, Exp 5/2020
- 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
- Recalling firm
- The Harvard Drug Group
- Quantity
- 678 cartons
- Distribution
- AL, FL, IA, NY, OH, TX
- Recall date
- May 20, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)