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Subpotent Drug: reduced efficacy for epinephrine
Cross contamination with other products.
Defective container: potential for non-sealed pouches which can lead to product leakage.
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
Presence of particulate matter: glass
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
CGMP Deviations: Out of specification for dissolution
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
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Subpotent drug: out of specification results
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.