Recall Enforment Report D-0027-2022

Drug Recall Enforcement Report Class II voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 10-08-2021 for 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 The product was recalled due to 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 ongoing.

Field Name Field Value
Event ID 88838 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0027-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Distributed Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall Out of specification result observed in a dissolution test at the 9-month long term stability time point. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 1,902 bottles Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 10-27-2021
Recall Initiation Date 10-08-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Lupin Pharmaceuticals Inc.
Code Info lot H002205, exp. date 08/2023 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 68180-314-06; 68180-314-01; 68180-315-06; 68180-315-01; 68180-316-01; 68180-316-06; 68180-317-06; 68180-317-01
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68180-314Imipramine Pamoate Imipramine PamoateCapsuleOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-315Imipramine Pamoate Imipramine PamoateCapsuleOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-316Imipramine Pamoate Imipramine PamoateCapsuleOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-317Imipramine Pamoate Imipramine PamoateCapsuleOralLupin Pharmaceuticals, Inc.Human Prescription Drug