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…

Recall date

October 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0222-2019

FDA classification

Class III

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Distributed nationwide in the USA and Puerto Rico

Why it was recalled

Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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