The Recall Desk
HighFDA (Drugs)·D-0968-2022·Announced 2022-06-08

Rocuronium Bromide Injection Recalled Due to Lack of Sterility Assurance

Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection pre-filled syringes nationwide due to lack of sterility assurance. Approximately 604,080 syringes are affected.

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 a Class II FDA recall of an injectable medication with no reported illnesses or injuries. Lack of sterility assurance represents a significant theoretical risk to injectable drug users, consistent with the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL pre-filled syringes due to lack of assurance of sterility. The recall affects approximately 604,080 syringes distributed nationwide.

The affected product is supplied in 5 x 5 mL pre-filled syringe packs and 6 x 5 syringe cartons. Specific lot codes affected are: RC1050A (Exp. 5/30/2022), RC1051B (Exp. 6/6/2022), RC1053A (Exp. 6/27/2022), RC2001A (Exp. 7/19/2022), RC2002A (Exp. 8/13/2022), RC2003A (Exp. 8/28/2022), and RC2004A (Exp. 9/8/2022). The product was manufactured by Nephron Sterile Compounding Center LLC at 4500 12th Street Extension, West Columbia, SC 29172.

Healthcare providers and hospitals should immediately discontinue use of the affected lot codes and quarantine any remaining product. Patients who have received this medication should contact their healthcare provider for guidance. No illnesses or adverse events related to this recall have been reported.

The recalled product

Product
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable / Parenteral
Hazard
  • lack-of-sterility
  • contamination-risk

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 (14)

  • Lots: RC1050A
  • Exp. 5/30/2022
  • RC1051B
  • Exp. 6/6/2022
  • RC1053A
  • Exp. 6/27/2022
  • RC2001A
  • Exp. 7/19/2022
  • RC2002A
  • Exp. 8/13/2022
  • RC2003A
  • Exp. 8/28/2022
  • RC2004A
  • Exp. 9/8/2022

Distribution

Distributed nationwide across the United States.

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