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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Failed Dissolution Specifications
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Sub-potent Drug
Subpotent drug: out of specification results
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Subpotent Drug
Failed Impurities/Degradation Specifications: Related Substances
CGMP Deviations
Failed Dissolution Specifications
Failed Dissolution Specifications
CGMP Deviations
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Defective Container
Defective Container
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Defective Container
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.