Recalls / Class III
Class IIID-0629-2020
Product
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
- Brand name
- Memantine Hydrochloride
- Generic name
- Memantine Hydrochloride
- Active ingredient
- Memantine Hydrochloride
- Route
- Oral
- NDCs
- 68180-246, 68180-249, 68180-247, 68180-248
- FDA application
- ANDA206028
- Affected lot / code info
- Lot #: H901787, H901788, Exp March 2021
Why it was recalled
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 3,726 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-12-10
- FDA classified
- 2019-12-23
- Posted by FDA
- 2019-12-25
- Terminated
- 2021-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0629-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.