Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
Maximum Strength Lidocaine Cold & Hot Patch
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk Ongoing
Mencaine
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk Ongoing
LidoPro
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk Ongoing
LidoPatch
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk Ongoing
Losartan Potassium Tablets
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk Ongoing
Losartan Potassium Tablets
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk Ongoing
Losartan Potassium Tablets
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk Ongoing
Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Ongoing
Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Ongoing
Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Ongoing
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz.
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Ongoing
Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Ongoing
Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Ongoing
Aurobindo Ranitidine Capsules 150 mg
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk Ongoing
Ranitidine Syrup
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk Ongoing
Aurobindo Ranitidine Capsules 300 mg
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.