Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC…
Reason Chemical Contamination; benzophenone leached from the product label varnish
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06
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.
Reason Chemical Contamination; benzophenone leached from the product label varnish
Reason Chemical Contamination; benzophenone leached from the product label varnish
Reason Chemical Contamination; benzophenone leached from the product label varnish
Reason Labeling: Label Mixup: IMIPRAMINE HCL, Tablet, 25 mg may have potentially been mislabeled as the following drug: FENOFIBRATE, Tablet, 54 mg, NDC…
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