Recall database
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
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).
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.
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.
Potential contamination with Listeria monocytogenes
Potential contamination with Listeria monocytogenes
Potential contamination with Listeria monocytogenes
Potential contamination with Listeria monocytogenes
Potential contamination with Listeria monocytogenes
Potential contamination with Listeria monocytogenes
Potential contamination with Listeria monocytogenes
Potential contamination with Listeria monocytogenes
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.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.