14,450 recalls · Class II, 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 interim acceptable daily intake level of 0.083 parts per million.
Reason Labeling: Label mix-up
Reason Labeling: Label mix-up
Reason Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Reason Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)
Reason Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Reason Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Reason Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Reason CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Reason CGMP Deviation; manufacturing batch record could not be located
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.