Calcium Gluconate Injection Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center is recalling 30,180 pre-filled Calcium Gluconate Injection syringes due to lack of sterility assurance. Affected lots CG1003A and CG2001A were 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: FDA Class II recall with no reported illnesses or hospitalizations. Lack of sterility assurance in an injectable product represents a risk-of-harm situation where injury has not yet been reported, per the severity rubric.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling 30,180 pre-filled syringes of Calcium Gluconate Injection, USP 10% (0.465 mEq Ca++/mL, 1 g/10 mL per syringe). The affected lots are CG1003A (expiration date 12/3/2022) and CG2001A (expiration date 2/10/2023). These products were distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility. Calcium Gluconate Injection is a sterile injectable medication that must meet strict sterility standards for patient safety.
Healthcare facilities, pharmacies, and distributors should immediately stop dispensing the affected lots and contact the manufacturer for return instructions. Patients who have received an injection from the recalled lots should contact their healthcare provider.
The recalled product
- Product
- Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectables
- Hazard
- Affected units
- 30,180
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 (4)
- Lots: CG1003A
- Exp. 12/3/2022
- CG2001A
- Exp. 2/10/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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.
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