436 recalls, newest first
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Reason GMP Deviations: A silicone particulate was noted in Ozurdex.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason Presence of Foreign Substance: foreign material found in the bulk inventory.
Reason Subpotent Drug; Ethinyl Estradiol
Reason Subpotent Drug; Ethinyl Estradiol
Reason Subpotent Drug; Ethinyl Estradiol
Reason Subpotent Drug; Ethinyl Estradiol
Reason Subpotent Drug; Ethinyl Estradiol
Reason Crystallization; Complaints that cream appears to have crystallized
Reason Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Reason Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
Reason Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of…
Reason Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
Reason Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Reason Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Reason Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Reason Chemical contamination: emission of strong odor after package was opened.
Reason Chemical contamination: emission of strong odor after package was opened.