FDA Recall
Terminated
Historical recordClass II
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01
by Mutual Pharmaceutical Company, Inc.
- Reason
- Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
- Published
- January 27, 2016
- Distribution
- MS
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FDA Recall
Terminated
Historical recordClass III
Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01
by Mutual Pharmaceutical Company, Inc.
- Reason
- Chemical Contamination; benzophenone leached from the product label varnish
- Published
- September 16, 2015
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01
by Mutual Pharmaceutical Company, Inc.
- Reason
- Chemical Contamination; benzophenone leached from the product label varnish
- Published
- September 16, 2015
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01
by Mutual Pharmaceutical Company, Inc.
- Reason
- Chemical Contamination; benzophenone leached from the product label varnish
- Published
- September 16, 2015
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01
by Mutual Pharmaceutical Company, Inc.
- Reason
- Chemical Contamination; benzophenone leached from the product label varnish
- Published
- September 16, 2015
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
by Mutual Pharmaceutical Company, Inc.
- Reason
- Chemical Contamination; benzophenone leached from the product label varnish
- Published
- September 16, 2015
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01
by Mutual Pharmaceutical Company, Inc.
- Reason
- Chemical Contamination; benzophenone leached from the product label varnish
- Published
- September 16, 2015
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01
by Mutual Pharmaceutical Company, Inc.
- Reason
- cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
- Published
- August 5, 2015
- Distribution
- Nartionwide
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FDA Recall
Terminated
Historical recordClass II
Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.
by Mutual Pharmaceutical Company, Inc.
- Reason
- cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
- Published
- August 5, 2015
- Distribution
- Nartionwide
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FDA Recall
Terminated
Historical recordClass II
Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA
by Mutual Pharmaceutical Company, Inc.
- Reason
- cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
- Published
- August 5, 2015
- Distribution
- Nartionwide
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FDA Recall
Terminated
Historical recordClass II
Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01
by Mutual Pharmaceutical Company, Inc.
- Reason
- Failed Impurities/Degradation Specifications: during long-term stability testing.
- Published
- March 25, 2015
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA
by Mutual Pharmaceutical Company, Inc.
- Reason
- 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
- Published
- January 15, 2014
- Distribution
- Nationwide
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This page lists recalls that name Mutual Pharmaceutical Company, Inc. as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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