October 2021 FDA Recall Imipramine Pamoate by Lupin Pharmaceuticals Inc.
D-0027-2022 - Out of specification result observed in a dissolution test at the 9-month long term stability time point.

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on October 8, 2021 for the product Imipramine Pamoate. The FDA reported the reason for recall as out of specification result observed in a dissolution test at the 9-month long term stability time point.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0027-2022

Reason for Recall
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Initiated
10-08-2021
Reported
10-27-2021
Quantity
1,902 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88838
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-13-2023
Product Description About Product Description
Full technical description of the product.
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

68180-314-06 Imipramine Pamoate
68180-314-01 Imipramine Pamoate
68180-315-06 Imipramine Pamoate
68180-315-01 Imipramine Pamoate
68180-316-06 Imipramine Pamoate
68180-316-01 Imipramine Pamoate
68180-317-06 Imipramine Pamoate
68180-317-01 Imipramine Pamoate