Why it was recalled
Lack of Assurance of Sterility
Product description
8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
Lot numbers, UPCs & expiration codes
Lots: SB2001A, Exp. 1/2/2023; SB2005B, SB2005C, Exp. 3/8/2023; SB2006A, SB2006B, SB2006C, Exp. 3/16/2023
Where it was sold
Nationwide in the USA
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-0950-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 18, 2022
- FDA report date
- Jun 8, 2022
- Quantity
- 13612 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Sterile Compounding Center LLC
Original FDA data
Every field from FDA enforcement report D-0950-2022, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 90211
- Address
- 4500 12th Street Ext
- Code information
- Lots: SB2001A, Exp. 1/2/2023; SB2005B, SB2005C, Exp. 3/8/2023; SB2006A, SB2006B, SB2006C, Exp. 3/16/2023
- Postal code
- 29172-3025
- Report date
- Jun 8, 2022
- Product type
- Drugs
- Recall number
- D-0950-2022
- Classification
- Class II
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Product quantity
- 13612 syringes
- Termination date
- Aug 23, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 18, 2022
- Initial firm notification
- Letter
- Center classification date
- May 27, 2022