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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
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