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All product recalls affecting Ohio.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Ohio in the distribution area.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Potential contamination with Listeria monocytogenes
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Potential contamination with Listeria monocytogenes
Potential contamination with Listeria monocytogenes
Potential contamination with Listeria monocytogenes
Potential contamination with Listeria monocytogenes
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
cGMP violations
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).