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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Defective Container - A defect in the side-seal which allows leakage of product.
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Defective container - seal not adhering to bottles
Defective container: cracked/broken cartridges
cGMP deviations
cGMP deviations
cGMP deviations
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Failed Stability Specifications: Observed OOS results: eg results for colour index
Defective container: cracked/broken cartridges
cGMP deviations
cGMP deviations
cGMP deviations
Defective container: cracked/broken cartridges
cGMP deviations
Defective container: cracked/broken cartridges