The Harvard Drug Group recalls Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufacture…
- Recall date
- December 13, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0844-2020
- FDA classification
- Class III
- Brand / firm
- The Harvard Drug Group
- Sold / distributed
- U.S.A. Nationwide
Why it was recalled
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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