Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA
Reported: December 25, 2019 Initiated: December 10, 2019 #D-0629-2020
Product Description
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA
Reason for Recall
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 3,726 bottles
- Distribution
- Nationwide in the USA
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 3,726 bottles.
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 December 25, 2019. Severity: Low. Recall number: D-0629-2020.
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