Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05

FDA recall notice · announced January 18, 2023 · Nephron Sterile Compounding Center

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05

Reason for recall

Lack of Assurance of Sterility

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot: RC2011A, Exp. 2/22/2023
Quantity: 38,830 syringes
Status: Terminated
Products in this recall event:
- Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, (D-0099-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.