Recall: D-0222-2019

Class III - Minor Violations

Class IIIClassification

2018-10-15Initiated

TerminatedStatus

Baxter Healthcare CorporationFirm

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

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.