Injectable Labetalol HCl Syringes Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center has recalled 115,640 units of Labetalol HCl Injection due to lack of assurance of sterility. The affected product 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: FDA Class II injectable drug recall where manufacturing processes failed to ensure product sterility. This qualifies as a risk-of-harm product; lack of sterility assurance in an injectable means serious infection could occur if contaminated product were administered to patients.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringes due to lack of assurance of sterility. The affected lots are LB1020A, LB1022A (Exp. 5/21/2022), LB2003A (Exp. 8/5/2022), and LB2007A (Exp. 9/20/2022).
Approximately 115,640 syringes were distributed nationwide in the United States. This is a prescription-only product manufactured at a Nephron 503B outsourcing facility located in West Columbia, South Carolina.
Healthcare providers and patients who have received or may receive this medication should consult with their healthcare provider. The affected syringes should not be used. Patients or healthcare providers with questions about this recall should contact the FDA or the manufacturer.
The recalled product
- Product
- Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Hazard
- Affected units
- 115,640
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 (6)
- Lots: LB1020A
- LB1022A Exp. 5/21/2022
- LB2003A
- Exp. 8/5/2022
- LB2007A
- Exp. 9/20/2022
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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