Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61
Reported: May 20, 2020 Initiated: April 24, 2020 #D-1262-2020
Product Description
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61
Reason for Recall
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Details
- Recalling Firm
- The Harvard Drug Group
- Units Affected
- 678 cartons
- Distribution
- AL, FL, IA, NY, OH, TX
- Location
- Livonia, MI
Frequently Asked Questions
What product was recalled? ▼
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61. Recalled by The Harvard Drug Group. Units affected: 678 cartons.
Why was this product recalled? ▼
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 20, 2020. Severity: Low. Recall number: D-1262-2020.
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