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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Failed Dissolution Specifications: below specification results
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Presence of Particulate Matter
Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
CGMP Deviations
Defective container; yellow colored spike from cap lodged in the nozzle
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
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)
Subpotent Drug: reduced efficacy for epinephrine
Cross contamination with other products.
Cross contamination with other products
Cross contamination with other products.
Cross contamination with other products
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Failed Dissolution Specifications: results below specifications