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Mutual Pharmaceutical Recalls
14 recalls on record · January 15, 2014 to January 27, 2016 · Drugs
Recalls by year
14
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 27, 2016DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutua
Hazard: Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
September 16, 2015DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC
Hazard: Chemical Contamination; benzophenone leached from the product label varnish
September 16, 2015DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC
Hazard: Chemical Contamination; benzophenone leached from the product label varnish
September 16, 2015DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA
Hazard: Chemical Contamination; benzophenone leached from the product label varnish
September 16, 2015DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA
Hazard: Chemical Contamination; benzophenone leached from the product label varnish
September 16, 2015DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, P
Hazard: Chemical Contamination; benzophenone leached from the product label varnish
September 16, 2015DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, P
Hazard: Chemical Contamination; benzophenone leached from the product label varnish
August 5, 2015DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA,
Hazard: cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
August 5, 2015DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-2
Hazard: cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
August 5, 2015DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-2
Hazard: cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
March 25, 2015DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELP
Hazard: Failed Impurities/Degradation Specifications: during long-term stability testing.
January 15, 2014DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489
Hazard: Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
January 15, 2014DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia
Hazard: Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
January 15, 2014DrugsFDA
Mutual Pharmaceutical Company, Inc. recalls FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90)
Hazard: Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots