FDAClass IIOctober 27, 2021

Imipramine Pamoate Capsules 125 mg recall: Failed Dissolution

Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States.…

Why was Imipramine Pamoate Capsules 125 mg recalled?

Out of specification result observed in a dissolution test at the 9-month long term stability time point.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

lot H002205, exp. date 08/2023

Product
Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States.…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
1,902 bottles
Distribution
Distributed Nationwide in the USA.
Recall date
October 27, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls