8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.
Reported: December 21, 2022 Initiated: November 28, 2022 #D-0079-2023
Product Description
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.
Reason for Recall
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Details
- Recalling Firm
- Exela Pharma Sciences LLC
- Units Affected
- 489,600 vials
- Distribution
- Nationwide within the United States
- Location
- Lenoir, NC
Frequently Asked Questions
What product was recalled? ▼
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.. Recalled by Exela Pharma Sciences LLC. Units affected: 489,600 vials.
Why was this product recalled? ▼
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 21, 2022. Severity: Critical. Recall number: D-0079-2023.
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