FDA-Drug2018-11-14Class III
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
Baxter Healthcare Corporation
Hazard
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Sold states
Distributed nationwide in the USA and Puerto Rico
Affected count
402,165 vials
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0222-2019Don't want to check this manually?
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