Class I - Dangerous
CGMP Deviations:
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Failed Impurity/Degradation Specifications
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
CGMP Deviations:
Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-586-01 (Individual Dose NDC: 60687-586-11)
Amerisource Health Services
Class I - Dangerous
Failed Impurities/Degradations Specifications
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
CGMP Deviations:
CGMP Deviations:
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.