FDAFDA · Food and drugs·Recall number D-0844-2020
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61
Published February 26, 2020 · Recall initiated: December 13, 2019
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: High out of specification result observed at stability studies.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MEMANTINE HYDROCHLORIDE
- Manufacturer
- The Harvard Drug Group
- Distributor
- U.S.A. Nationwide
- Lot
- Lot# M02465D
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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