D-1424-2015 Class III Terminated
FDA drug recall D-1424-2015 was initiated by Mutual Pharmaceutical Company, Inc. on July 16, 2015 and is designated Class III. Reason for recall: Chemical Contamination; benzophenone leached from the product label varnish The recall status is terminated (terminated October 13, 2016). Affected quantity: 14,112 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 16, 2015
- Initiation Date
- July 16, 2015
- Termination Date
- October 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,112 bottles
Product Description
Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01
Reason for Recall
Chemical Contamination; benzophenone leached from the product label varnish
Distribution Pattern
Nationwide
Code Information
lot #s: 6655001, exp 8/16, 6679801, exp 2/17, 6690302, exp 4/17 and 6706001, exp 7/17