Lupin Pharmaceuticals Inc. recalls Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-c…
- Recall date
- December 10, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0629-2020
- FDA classification
- Class III
- Brand / firm
- Lupin Pharmaceuticals Inc.
- Sold / distributed
- Nationwide in the USA
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 a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA
Get recall alerts
Free email alert whenever Lupin Pharmaceuticals Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Lupin Pharmaceuticals Inc.