Why it was recalled
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0022-2023
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 4, 2022
- FDA report date
- Nov 2, 2022
- Quantity
- 2,123,040 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Exela Pharma Sciences LLC
Original FDA data
Every field from FDA enforcement report D-0022-2023, exactly as published.
Show all FDA fields
- City
- Lenoir
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 90956
- Address
- 1245 Blowing Rock Blvd
- Code information
- 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.
- Postal code
- 28645-3618
- Report date
- Nov 2, 2022
- Product type
- Drugs
- Recall number
- D-0022-2023
- Classification
- Class I
- Recalling firm
- Exela Pharma Sciences LLC
- Product quantity
- 2,123,040 vials
- Termination date
- Oct 10, 2025
- Reason for recall
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 4, 2022
- Initial firm notification
- Letter
- Center classification date
- Oct 27, 2022