Baxter Healthcare Corporation recalls Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured
Recalled November 14, 2018 · FDA recall D-0222-2019 · Baxter Healthcare
Hazard
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots. · FDA Class III
Units
402,165 vials
Sold at
Distributed nationwide in the USA and Puerto Rico
Description
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Product
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
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →