Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10
Recall Number: D-0222-2019
Firm: Baxter Healthcare Corporation
Classification: Class III
Status: Terminated
Report Date: 20181114
Initiation Date: 20181015
Termination Date: 20220812
Reason for Recall
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Product Description
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10