The Recall Desk
LowFDA (Drugs)·D-1424-2015·Announced 2015-09-16

Mutual Pharmaceutical Recalls Imipramine HCl Tablets Due to Chemical Contamination

Mutual Pharmaceutical is recalling specific lots of Imipramine HCl tablets because benzophenone leached from the label varnish.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Mutual Pharmaceutical Company, Inc. is recalling 14,112 bottles of Imipramine HCl Tablets, USP, 25 mg, 100 count. The affected product is identified by NDC 54738-913-01 and includes lot numbers 6655001 (exp 8/16), 6679801 (exp 2/17), 6690302 (exp 4/17), and 6706001 (exp 7/17). The recall was initiated due to chemical contamination, specifically benzophenone leaching from the product label varnish.

The affected bottles were distributed nationwide. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers who have these specific lots of Imipramine HCl tablets should stop using them and contact their pharmacist or healthcare provider for guidance on replacement or disposal.

The recalled product

Product
Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01
Manufacturer
Mutual Pharmaceutical Company, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
14,112

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • lot #s: 6655001
  • exp 8/16
  • 6679801
  • exp 2/17
  • 6690302
  • exp 4/17 and 6706001
  • exp 7/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Mutual Pharmaceutical Company, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Mutual Pharmaceutical Company, Inc.

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Same hazard · chemical contamination

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