Imipramine Pamoate Capsule
FDA Recall NDC 68180-317
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Imipramine Pamoate (NDC 68180-317). A significant event, classified as Class II, was initiated on Oct 08, 2021 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Out of specification result observed in a dissolution test at the 9-month long term stability time point."
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
October 2021 Class II Recall: Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Recall Number
Class II Terminated
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Oct 08, 2021
Oct 27, 2021
1,902 bottles
Recall Profile & Regulatory Data
Event ID
88838
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA.
Termination Date
Mar 13, 2023
Product Description
Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06
Batch or Lot Expiration Information
Lot# lot H002205, exp. date 08/2023
Affected Packages Involved in this Recall
68180-314-06Product
68180-314-01Product
68180-315-06Product
68180-315-01Product
68180-316-06Product
68180-316-01Product
68180-317-06Product
68180-317-01Product
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.
