FDA recall D-0222-2019

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

Reason for recall

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

Distribution

Distributed nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-10-15

Report date

2018-11-14

Termination date

2022-08-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0222-2019