FDA alert – Voluntary Recall – Potential Impact on Product Sterility

ISSUE: 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,…

Heritage Initiates a Voluntary Recall Due to a Lack of Sterility Assurance

FDA PRESS, FOR IMMEDIATE RELEASE — February 24, 2015 — Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure…