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Mutual Pharmaceutical Company, Inc.

Mutual Pharmaceutical Company, Inc. Recalls

All product recalls associated with Mutual Pharmaceutical Company, Inc..

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Recall Summary

Total Recalls

14

Past Year

0

Class I (Serious)

0

Most Recent

Oct 2015

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–14 of 14 recalls

Sulfamethoxazole Tablets (Mutual Pharmaceutical) – Foreign Substance (2015)

Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.

Class IIModerate

FDAOct 9, 2015MS• Mutual Pharmaceutical Company, Inc.

Imipramine HCl 50 mg (Mutual) – Chemical Contamination (2015)

Chemical Contamination; benzophenone leached from the product label varnish

FDAJul 16, 2015Nationwide• Mutual Pharmaceutical Company, Inc.

Imipramine HCl 25 mg (Mutual) – Chemical Contamination (2015)

Chemical Contamination; benzophenone leached from the product label varnish

Low

FDAJul 16, 2015Nationwide• Mutual Pharmaceutical Company, Inc.

Imipramine HCl 10 mg (Mutual) – Chemical Contamination (2015)

Chemical Contamination; benzophenone leached from the product label varnish

FDAJul 16, 2015Nationwide• Mutual Pharmaceutical Company, Inc.

Felodipine 5 mg (Mutual) – Chemical Contamination (2015)

Chemical Contamination; benzophenone leached from the product label varnish

FDAJul 16, 2015Nationwide• Mutual Pharmaceutical Company, Inc.

Felodipine 2.5 mg (Mutual) – Chemical Contamination (2015)

Chemical Contamination; benzophenone leached from the product label varnish

FDAJul 16, 2015Nationwide• Mutual Pharmaceutical Company, Inc.

Felodipine 10 mg (Mutual) – Chemical Contamination (2015)

Chemical Contamination; benzophenone leached from the product label varnish

FDAJul 16, 2015Nationwide• Mutual Pharmaceutical Company, Inc.

Clonidine Tablets 0.1mg (Mutual) – manufacturing deviation (2015)

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

Class IIModerate

FDAJul 9, 2015Nationwide• Mutual Pharmaceutical Company, Inc.

Clonidine Tablets 0.2mg (Mutual) – manufacturing deviation (2015)

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

Class IIModerate

FDAJul 9, 2015Nationwide• Mutual Pharmaceutical Company, Inc.

Clonidine Tablets 0.3mg (Mutual) – manufacturing deviation (2015)

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

Class IIModerate

FDAJul 9, 2015Nationwide• Mutual Pharmaceutical Company, Inc.

Ergoloid Mesylates (Mutual Pharmaceutical) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications: during long-term stability testing.

Class IIModerate

FDAMar 10, 2015Nationwide• Mutual Pharmaceutical Company, Inc.

Fenofibric Acid Tablets (Mutual Pharmaceutical) – Incorrect Labeling (2013)

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

FDAFeb 27, 2013Nationwide• Mutual Pharmaceutical Company, Inc.

FIBRICOR Tablets (Mutual Pharmaceutical) – Incorrect Labeling (2013)

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

FDAFeb 27, 2013Nationwide• Mutual Pharmaceutical Company, Inc.

Fenofibric Acid Tablets (Mutual Pharmaceutical) – Incorrect Labeling (2013)

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

FDAFeb 27, 2013Nationwide• Mutual Pharmaceutical Company, Inc.