Memantine Hydrochloride Capsule, Extended Release
FDA Recall NDC 68180-246
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Memantine Hydrochloride (NDC 68180-246). A significant event, classified as Class II, was initiated on Feb 12, 2020 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Feb 12, 2020
Feb 19, 2020
6,294 bottles
Recall Profile & Regulatory Data
Event ID
84948
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States.
Termination Date
Jun 03, 2021
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
Batch or Lot Expiration Information
Lot# : H900330, exp. date 11/2020.
Affected Packages Involved in this Recall
68180-246-06Product
68180-249-06Product
68180-249-09Product
68180-249-02Product
68180-247-06Product
68180-247-09Product
68180-248-06Product
Class III Terminated
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Dec 10, 2019
Dec 25, 2019
3,726 bottles
Recall Profile & Regulatory Data
Event ID
84463
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Apr 29, 2021
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
Batch or Lot Expiration Information
Lot# : H901787, H901788, Exp March 2021
Affected Packages Involved in this Recall
68180-246-06Product
68180-249-06Product
68180-249-09Product
68180-249-02Product
68180-247-06Product
68180-247-09Product
68180-248-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
