Status
Completed
Drug Enforcement D-0079-2023
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Classification
Class I
Report Date
December 21, 2022
Termination Date
—
Product Information
- 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.
- Product quantity
- 489,600 vials
- Reason for recall
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Exela Pharma Sciences LLC
- Address
-
1245 Blowing Rock Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0079-2023
- Event ID
- 91197
- Recall initiation date
- November 28, 2022
- Center classification date
- December 13, 2022
- 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.
- More code info
- —