US Drug Recall Register
Class III · Low risk Terminated Initiated Oct 15, 2018 (8 years ago)

Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

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

Recalling firm
Baxter Healthcare Corporation
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0222-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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