Sodium Bicarbonate Injection Recalled for Lack of Sterility Assurance

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling 13,612 pre-filled syringes of 8.4% Sodium Bicarbonate Injection, USP (1 mEq/mL, 4.2 g/50 mL). The affected product includes cartons of 10 units and cartons of 30 units, with the following lot numbers and expiration dates: SB2001A (exp. 1/2/2023), SB2005B and SB2005C (exp. 3/8/2023), and SB2006A, SB2006B, and SB2006C (exp. 3/16/2023). The product is identified by NDC 69374-214-50 and was compounded at the Nephron 503B outsourcing facility located at 4500 12th Street Extension, West Columbia, South Carolina.

The U.S. Food and Drug Administration has classified this as a Class II recall due to lack of assurance of sterility. This means the product cannot be verified to meet sterility requirements for injectable medication.

The recalled product was distributed nationwide. Healthcare providers and facilities who have received or dispensed this product should verify the lot numbers and expiration dates against the affected batches listed above.

The recalled product

Product

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

Manufacturer

Nephron Sterile Compounding Center LLC

Category

Drug — Injectable / Sterile Compounding

Hazard

• sterility-contamination
• infectious-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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