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Failed Impurities/Degradation Specifications:
Superpotent drug
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Presence of a foreign substance.
Discoloration