Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets USP 750 mg
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Ongoing
Killz Germz Hand Sanitizer
Reason Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Class II · Moderate risk Ongoing
Killz Germz Hand Sanitizer
Reason Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Class II · Moderate risk Ongoing
Genesis Hand Sanitizer Gel
Reason CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Class II · Moderate risk Ongoing
Genesis Hand Sanitizer Gel
Reason CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Class II · Moderate risk Ongoing
Panagel Hand Sanitizer
Reason CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Class II · Moderate risk Ongoing
Elitek
Reason Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Class II · Moderate risk Ongoing
Next Advanced Antibacterial Hand Sanitizer
Reason CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk Ongoing
Assured Instant Hand Sanitizer Vitamin E and Aloe
Reason CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk Ongoing
Assured Instant Hand Sanitizer Aloe & Moisturizers
Reason CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk Ongoing
Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera
Reason CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk Ongoing
NuuxSan Instant ANTIBACTERIAL HAND SANITIZER
Reason CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets USP
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
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
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
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
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