The Harvard Drug Group recalls Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by:…
- Recall date
- April 24, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1262-2020
- FDA classification
- Class III
- Brand / firm
- The Harvard Drug Group
- Sold / distributed
- AL, FL, IA, NY, OH, TX
Why it was recalled
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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