D-0844-2020 Class III Terminated
FDA drug recall D-0844-2020 was initiated by The Harvard Drug Group on December 13, 2019 and is designated Class III. Reason for recall: Failed Dissolution Specifications: High out of specification result observed at stability studies. The recall status is terminated (terminated November 4, 2020). Affected quantity: 246 Cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- February 26, 2020
- Initiation Date
- December 13, 2019
- Termination Date
- November 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 246 Cartons
Product Description
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
Reason for Recall
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot# M02465D