FDAClass IIISeptember 16, 2015

Imipramine HCl Tablets recall: Contamination

Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01

Why was Imipramine HCl Tablets recalled?

Chemical Contamination; benzophenone leached from the product label varnish

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?

lots# 6671901, exp 12/16, 6679901, exp 2/17, 6694201, exp 5/17, 6697901, exp 6/17 and 6704201, exp 7/17

Product
Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01
Recalling firm
Mutual Pharmaceutical Company, Inc.
Quantity
10,080 bottles
Distribution
Nationwide
Recall date
September 16, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls