Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Mutual Pharmaceutical Company
Class I - Dangerous
Chemical Contamination; benzophenone leached from the product label varnish
Class I - Dangerous
Chemical Contamination; benzophenone leached from the product label varnish
Class I - Dangerous
Chemical Contamination; benzophenone leached from the product label varnish
Class I - Dangerous
Chemical Contamination; benzophenone leached from the product label varnish
Class I - Dangerous
Chemical Contamination; benzophenone leached from the product label varnish
Class I - Dangerous
Chemical Contamination; benzophenone leached from the product label varnish
Class I - Dangerous
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Failed Impurities/Degradation Specifications: during long-term stability testing.
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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
Class I - Dangerous
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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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