2,661 recalls, newest first
Reason Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Reason Subpotent Drug: reduced efficacy for epinephrine
Reason Cross contamination with other products.
Reason Cross contamination with other products.
Reason CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Reason Failed Dissolution Specifications: results below specifications
Reason Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Reason Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Reason Failed Dissolution Specifications
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Reason Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Reason Sub-potent Drug
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations