Status
Completed
Drug Enforcement D-0022-2023
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
1 Views
Classification
Class I
Report Date
November 2, 2022
Termination Date
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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
- 2,123,040 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
- Letter
- 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-0022-2023
- Event ID
- 90956
- Recall initiation date
- October 4, 2022
- Center classification date
- October 27, 2022
- 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.
- More code info
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