Labetalol HCl Injection Recalled for Manufacturing Cross-Contamination Risk
Nephron Sterile Compounding Center is recalling PF-Labetalol HCl Injection nationwide due to manufacturing deviations that create potential for cross-contamination. No illnesses have been reported.
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 FDA Class II recall addresses potential manufacturing contamination in a sterile injectable product. Although no illnesses have been reported and the hazard remains theoretical, the risk posed by contamination in a sterile injectable medication warrants a High severity classification.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL). The recall affects 33,870 vials (lot LB2005A, expiration date 3/2/2023) that were distributed nationwide.
The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. Specifically, there is potential for cross-contamination of the product due to carryover during the manufacturing process.
No illnesses or injuries have been reported in association with this recall.
The recalled product
- Product
- PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug
- Hazard
- Affected units
- 33,870
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)
- Lot: LB2005A
- Exp 3/2/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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