Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
American Pharmaceutical Ingredients LLCNDC 58597-8198-3D-0479-2018
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
American Pharmaceutical Ingredients LLCNDC 58597-8635-4D-0478-2018
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
American Pharmaceutical Ingredients LLCNDC 58597-8630-1D-0477-2018
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
American Pharmaceutical Ingredients LLCNDC 58597-8004-4D-0476-2018
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
American Pharmaceutical Ingredients LLCNDC 58597-8080-1D-0475-2018
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
American Pharmaceutical Ingredients LLCNDC 58597-8003-4D-0474-2018
Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may…
Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may…
Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may…
Reason Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for…
Sun Pharmaceutical Industries, Inc.NDC 47335-779-91D-0417-2018