Drug product
Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01
D-1425-2015
Product summary
- Event
- Event 71836
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10,080 bottles
- Official record key
drug-enforcement:D-1425-2015
Official wording
Reason: Chemical Contamination; benzophenone leached from the product label varnish
Code information: lots# 6671901, exp 12/16, 6679901, exp 2/17, 6694201, exp 5/17, 6697901, exp 6/17 and 6704201, exp 7/17
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination