FDAFDA · Food and drugs·Recall number D-1262-2020
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
Published May 20, 2020 · Recall initiated: April 24, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MEMANTINE HYDROCHLORIDE
- Manufacturer
- The Harvard Drug Group
- Distributor
- AL, FL, IA, NY, OH, TX
- Lot
- Lot #: M02199D, M02246D, Exp 5/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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