Class I
Terminated
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.
This recall has been terminated (originally issued December 21, 2022).
- Company
- Exela Pharma Sciences Llc
- Recall Initiated
- November 28, 2022
- Posted
- December 21, 2022
- Recall Number
- D-0079-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 489,600 vials
- Firm Location
- Lenoir, NC, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Distribution
Nationwide within the United States
Lot / Code Info
Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464 Exp. 09/2023; P0001442 Exp. 11/2023; P0001467, P0001472, P0001486, P0001532 Exp. 12/2023.
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