The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1247-2022·Announced 2022-07-27

Bupivacaine Injection Recalled Due to Lack of Sterility Assurance

Nephron Sterile Compounding Center is recalling 6900 syringes of Bupivacaine HCl Injection nationwide due to lack of sterility assurance. No illnesses or injuries 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 is an FDA Class II recall for an injectable pharmaceutical product lacking sterility assurance. Although no illnesses or injuries have been reported, injectable products with compromised sterility represent a direct risk of harm to patients who would receive the medication.

Plain-English summary

Nephron Sterile Compounding Center LLC, a 503B outsourcing facility, is recalling 0.125% Bupivacaine HCl Injection, USP (1.25 mg/mL) in pre-filled syringes due to lack of assurance of sterility.

The recalled product was distributed nationwide. It consists of pre-filled 50 mL syringes in cartons of 5, packaged 6 cartons per case (NDC 69374-970-50). Approximately 6900 syringes have been recalled across eight lot numbers—BH2001A through BH2010A—with expiration dates ranging from July 15, 2022 to October 19, 2022.

No illnesses or injuries have been reported in connection with this recall. Customers and healthcare providers with questions about the affected product should contact Nephron Sterile Compounding Center LLC or the U.S. Food and Drug Administration.

The recalled product

Product
0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext., West Columbia, SC 29172, NDC: 69374-970-50
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable / Local Anesthetic
Hazard
Affected units
6,900

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 (16)

  • Lots: BH2001A
  • Exp. 7/15/2022
  • BH2002A
  • Exp. 8/7/2022
  • BH2004A
  • Exp. 8/22/2022
  • BH2005A
  • Exp. 9/2/2022
  • BH2006A
  • Exp. 9/14/2022
  • BH2007A
  • Exp. 9/29/2022
  • BH2008A
  • Exp. 10/3/2022
  • BH2010A
  • Exp. 10/19/2022

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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