Class I - Dangerous
Lack of Assurance of Sterility
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Lack of Assurance of Sterility
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
Aurobindo Pharma USA
Class I - Dangerous
Superpotent and Failed Tablet/Capsule Specifications
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
cGMP deficiencies
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.