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
- Affected units
- 604,080
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.
Part of a larger recall action
This product is one of 20 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 20 products in this recall →Related recalls
Same manufacturer · Nephron Sterile Compounding Center LLC
See all →- HighSodium Chloride Injection Recalled for Potential Sterility Compromise
FDA (Drugs) · 2025-03-19
- HighNorepinephrine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-03-08
- HighNephron Phenylephrine HCl Injection Recalled for Sterility Assurance
FDA (Drugs) · 2023-03-08
- HighDiltiazem HCl Injectable Drug Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-03-08
- HighFDA Recalls Norepinephrine Injection Due to Sterility Concerns
FDA (Drugs) · 2023-03-08
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15