Class II · Moderate risk
Imipramine Pamoate Capsules 125 mg
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
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
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
Affected NDC
54738-0912-01
Compare with the code on your package — it is the most precise check available.
Drug: Imipramine
- 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 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Imipramine recalls
See all
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class II · Moderate risk
Imipramine HCL
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.
Other recalls by Mutual Pharmaceutical Company, Inc.
All 2015 recalls
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
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