Class II · Moderate risk Terminated
Imipramine Pamoate Capsules 125 mg
Reason Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Imipramine HCl Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Chemical Contamination; benzophenone leached from the product label varnish
What was recalled
Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
- NDC code
- 54738-912-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1423-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Imipramine recalls
See all
Class III · Low risk Terminated
Imipramine HCl Tablets
Reason Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk Terminated
Imipramine HCl Tablets
Reason Chemical Contamination; benzophenone leached from the product label varnish
Class II · Moderate risk Terminated
Imipramine HCL
Reason Labeling: Label Mixup: IMIPRAMINE HCL, Tablet, 25 mg may have potentially been mislabeled as the following drug: FENOFIBRATE, Tablet, 54 mg, NDC 00115551110, Pedigree: AD49448_7, EXP: 5/17/2014.
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