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 November 2, 2022).
- Company
- Exela Pharma Sciences Llc
- Recall Initiated
- October 4, 2022
- Posted
- November 2, 2022
- Recall Number
- D-0022-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,123,040 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
Lot # : P0001370, P0001371, P0001372, Exp. 10/2023; P0001433, P0001434 Exp. 11/2023; P0001443, P0001468, P0001469, P0001470, P0001495, P0001505, P0001506, P0001509, P0001510, P0001511, P0001512 Exp. 12/2023; P0001560, P0001561, P0001562, P0001564, P0001566, P0001567, P0001568 Exp. 01/2024; P0001571, P0001572, P0001573, P0001574, P0001578, P0001579, P0001580, P0001583, P0001586, P0001587, P0001588, P0001593, P0001594, P0001610, P0001618, P0001619, P0001654 Exp. 02/2024; P0001644, P0001645, P0001646, P0001662, P0001664 Exp. 03/2024; P0001730 Exp. 05/2024.