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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.
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
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Cross contamination with other products.
Failed Dissolution Specifications: results below specifications
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Failed Dissolution Specifications
Sub-potent Drug
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.
Subpotent drug: out of specification results