FDA recall D-0245-2019

Product

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

Reason for recall

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

Distribution

1 vial was distributed to a medical facility in Mayville, NY.

Key facts

Status

Terminated

Initiation date

2018-10-26

Report date

2018-11-21

Termination date

2019-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0245-2019