778 recalls, newest first
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Reason Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Reason Marketed Without an Approved NDA/ANDA
Reason Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation…
Reason Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Reason Presence of a foreign substance: black hair found embedded in tablet.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Discoloration; discolored solution from cracked vials
Reason Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Reason CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Reason Presence of foreign tablets/capsules.
Reason Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of…
Reason Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of…
Reason Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Reason cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Reason Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Reason Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and…