The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1262-2022·Announced 2022-07-27

Labetalol Injection Recalled Nationwide Over Sterility Assurance Defect

Nephron Sterile Compounding Center is recalling 184,370 syringes of Labetalol HCl Injection nationwide due to lack of assurance of sterility. Patients using the affected lots should contact their healthcare provider.

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 is an FDA Class II manufacturing defect involving loss of sterility assurance in injectable medication. No illnesses or injuries have been reported, but this qualifies as a risk-of-harm product where injury has not yet been reported, fitting the High severity category per the rubric.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) pre-filled syringes. The recall affects 184,370 syringes from four lots: LB2002A (expiring 7/12/2022), LB2004A (expiring 8/21/2022), LB2006A (expiring 9/3/2022), and LB2008A (expiring 10/6/2022). The product was manufactured at the facility located at 4500 12th Street Extension, West Columbia, South Carolina 29172.

The recall is due to a lack of assurance of sterility in the affected lots. This is a prescription injectable medication, and sterility is critical to patient safety when a product is administered directly into the body.

The affected product was distributed nationwide throughout the United States. Patients currently using or with prescriptions for Labetalol HCl Injection from the affected lots should contact their healthcare provider or pharmacist immediately.

Healthcare providers and pharmacies should discontinue use of the recalled lots and quarantine any remaining product from the affected batches. Patients should not attempt to use the medication and should consult their healthcare provider about alternative treatment options.

The recalled product

Product
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable
Hazard
Affected units
184,370

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 (8)

  • Lots: LB2002A
  • Exp. 7/12/2022
  • LB2004A
  • Exp. 8/21/2022
  • LB2006A
  • Exp. 9/3/2022
  • LB2008A
  • Exp. 10/6/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 37 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.

See all 37 products in this recall →

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