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
17,898 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
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 Terminated
Unasyn
Reason Presence of Particulate Matter: particulate matter identified after reconstitution.
Class II · Moderate risk Terminated
Gaviscon Liquid Antacid Extra Strength
Reason Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk Terminated
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry
Reason Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk Terminated
Gaviscon Regular Strength Liquid Antacid Cool Mint
Reason Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk Terminated
Gaviscon Regular Strength Liquid Antacid Cool Mint
Reason Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk Terminated
oxyTOCIN 30 Units/500 mL
Reason Subpotent drug - Product did not contain drug.
Class II · Moderate risk Terminated
Lisinopril Tablets
Reason Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Class III · Low risk Terminated
Lamotrigine Tablets
Reason Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Class III · Low risk Terminated
Duavee
Reason Failed Dissolution Specifications
Class II · Moderate risk Completed
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Class III · Low risk Terminated
Olanzapine Tablets
Reason Failed Impurities/ Degradation Specifications
Class III · Low risk Terminated
Olanzapine Tablets
Reason Failed Impurities/ Degradation Specifications
Class III · Low risk Terminated
Clonidine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Class III · Low risk Terminated
Lamotrigine Tablets
Reason Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.