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
Reported: February 26, 2020 Initiated: December 13, 2019 #D-0844-2020
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.
Details
- Recalling Firm
- The Harvard Drug Group
- Units Affected
- 246 Cartons
- Distribution
- U.S.A. Nationwide
- Location
- Livonia, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by The Harvard Drug Group. Units affected: 246 Cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 26, 2020. Severity: Low. Recall number: D-0844-2020.
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