Recall of Atracurium Besylate injection by Sagent Pharmaceuticals

0

FDA report “Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility.”

Full Alert

Thank you to our partners for supporting IVTEAM

Share.

Comments are closed.

Free Email Updates
Join 5.5K IVTEAM members. Subscribe now and be the first to receive all the latest free updates from IVTEAM!
100% Privacy. We don't spam.