Reason Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found…
Reason cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the…
Reason Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled…
Reason Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and…
Hetero Labs Limited Unit VNDC 31722-705-30D-0602-2018
Reason Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and…
Hetero Labs Limited Unit VNDC 31722-832-60D-0601-2018
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 58597-8276-3D-0539-2018
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 58597-8044-1D-0538-2018
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 58597-8142-1D-0537-2018
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 58597-8142-1D-0536-2018
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 58597-8120-6D-0535-2018
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 58597-8039-6D-0534-2018
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 58597-8575-2D-0533-2018
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 58597-8091-4D-0532-2018
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 58597-8038-6D-0531-2018
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 58597-8033-2D-0530-2018