Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06
Reported: February 19, 2020 Initiated: February 12, 2020 #D-0855-2020
Product Description
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06
Reason for Recall
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 6,294 bottles
- Distribution
- Nationwide within the United States.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 6,294 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 19, 2020. Severity: Moderate. Recall number: D-0855-2020.
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