US Drug Recall Register
Class III · Low risk Terminated Initiated Oct 26, 2018 (8 years ago)

Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences…

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

Why it was recalled

Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.

What was recalled

Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00

Recalling firm
RemedyRepack Inc.
NDC code
70518-0868-00
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0245-2019

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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