Recalls / Class III
Class IIID-0844-2020
Product
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
- Brand name
- Memantine Hydrochloride
- Generic name
- Memantine Hydrochloride
- Active ingredient
- Memantine Hydrochloride
- Route
- Oral
- NDCs
- 0904-6734, 0904-6736, 0904-6737, 0904-6735
- FDA application
- ANDA206028
- Affected lot / code info
- Lot# M02465D
Why it was recalled
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Recalling firm
- Firm
- The Harvard Drug Group
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr Ste 233, Livonia, Michigan 48152-3951
Distribution
- Quantity
- 246 Cartons
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-12-13
- FDA classified
- 2020-02-14
- Posted by FDA
- 2020-02-26
- Terminated
- 2020-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0844-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.