Drug product
Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01
D-1424-2015
Product summary
- Event
- Event 71836
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,112 bottles
- Official record key
drug-enforcement:D-1424-2015
Official wording
Reason: Chemical Contamination; benzophenone leached from the product label varnish
Code information: lot #s: 6655001, exp 8/16, 6679801, exp 2/17, 6690302, exp 4/17 and 6706001, exp 7/17
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination