FDA Recalls Labetalol Injectable for Potential Cross-Contamination Risk
FDA recalls Nephron's Labetalol HCl Injection vials due to manufacturing deviations that could cause cross-contamination. The recall affects 34,020 vials distributed nationwide.
What this means for you
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 FDA Class II recall of an injectable drug with potential cross-contamination from manufacturing deviations. Per the rubric, recalls with theoretical hazards score at most 3 (High).
Plain-English summary
The FDA has recalled PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vials manufactured by Nephron Sterile Compounding Center LLC. The affected lots are LB2001B (Exp. 01/07/2023) and LB2005B (Exp. 03/02/2023), with 34,020 vials distributed nationwide.
The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. Specifically, the deviations created potential for cross-contamination due to product carryover between batches.
Healthcare facilities and pharmacies that received vials from the affected lot numbers should verify their inventory and discontinue use of any recalled product. Consult with appropriate healthcare personnel and the FDA for guidance on alternative medications and product handling.
The recalled product
- Product
- PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable
- Affected units
- 34,020
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 (2)
- Lots: LB2001B Exp. 01/07/2023
- LB2005B Exp. 03/02/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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