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
Reported: November 14, 2018 Initiated: October 15, 2018 #D-0222-2019
Product Description
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 402,165 vials
- Distribution
- Distributed nationwide in the USA and Puerto Rico
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Baxter Healthcare Corporation. Units affected: 402,165 vials.
Why was this product recalled? ▼
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 14, 2018. Severity: Low. Recall number: D-0222-2019.
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