557 recalls, newest first
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Reason Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the…
Reason Failed Dissolution Specifications
Reason Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection…
Reason Subpotent Drug: reduced efficacy for epinephrine
Reason Defective container: potential for non-sealed pouches which can lead to product leakage.
Reason Cross contamination with other products
Reason Cross contamination with other products
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…
Reason Presence of particulate matter: glass
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 CGMP Deviations: Out of specification for dissolution
Reason CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Reason CGMP Deviations and Presence of Particulate Matter: Glass
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%.