Agency classClass IIOur severity:High FDA (Drugs)·D-1279-2022·Announced 2022-07-27

Sodium Bicarbonate Injection USP recalled for lack of sterility assurance

Nephron Sterile Compounding Center recalls 36,354 pre-filled syringes of Sodium Bicarbonate Injection due to lack of sterility assurance. The medication was distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an injectable drug with potential contamination risk due to lack of sterility assurance. Although no illnesses or injuries have been reported, the product category (sterile injectable) and nature of the hazard (uncertain sterility) present significant risk of harm if the product is used, meeting the criterion for High (score 3).

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Sodium Bicarbonate Injection USP in pre-filled syringes due to lack of assurance of sterility. Approximately 36,354 syringes from 14 affected lots (SB2001B through SB2009B, with expiration dates from January to April 2023) are subject to this recall.

The FDA classified this as a Class II recall. The product was distributed nationwide in the United States.

Healthcare providers should verify lot numbers and expiration dates against the affected lots listed in the recall. Doses from the recalled lots should not be used. Patients and providers should contact the manufacturer or FDA for additional information and guidance.

The recalled product

Product: 8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, 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 Medication
Hazard: contamination-risk
Affected units: 36,354

Is your product affected?

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

Lot numbers (20)

Lots: SB2001B
Exp. 1/2/2023
SB2001C
SB2003A
Exp. 2/14/2023
SB2003B
SB2003C
SB2004A
Exp. 3/1/2023
SB2004B
SB2004C
SB2005A
Exp. 3/8/2023
SB2007A
Exp. 3/22/2023
SB2007B
SB2008A
Exp. 3/29/2023
SB2008B
SB2009A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 37 recalled by Nephron Sterile Compounding Center LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 37 products in this recall →

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · contamination risk