Recalls / Class II
Class IID-0855-2020
Product
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06
- 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 #: H900330, exp. date 11/2020.
Why it was recalled
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
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
- 6,294 bottles
- Distribution pattern
- Nationwide within the United States.
Timeline
- Recall initiated
- 2020-02-12
- FDA classified
- 2020-02-24
- Posted by FDA
- 2020-02-19
- Terminated
- 2021-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0855-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.