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
Reported: July 27, 2022 Initiated: June 30, 2022 #D-1279-2022
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Nephron Sterile Compounding Center LLC
- Units Affected
- 36,354 syringes
- Distribution
- Nationwide in the USA
- Location
- West Columbia, SC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 36,354 syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 27, 2022. Severity: Moderate. Recall number: D-1279-2022.
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