CLASS II Drug recall · Reported 18 Jan 2023 · FDA Enforcement Report
Rocuronium Bromide Injection, 50 mg/ (10 mg/mL) recalled
Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection, 50 mg/ (10 mg/mL), mL Pre-Filled Syringe, syringe, distributed nationwide in the US. The recall was initiated on 6 Jan 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0099-2023
- FDA event ID
- 91450
- Recalling firm
- Nephron Sterile Compounding Center, West Columbia, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jan 2023
- FDA classified
- 9 Jan 2023
- Reported
- 18 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Jan 2023 | Recall initiated by company | |
| 9 Jan 2023 | Classified by FDA | +3 days |
| 18 Jan 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot: RC2011A, Exp. 2/22/2023
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nephron Sterile Compounding Center
All 73| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Chloride Injection 9%, USP, Single-Dose IV recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection, USP, 0.8 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection, USP, 0.4 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
Other Rocuronium recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rocuronium Bromide Injection, Preservative Free, 10 mg / mL recalledRocuronium Bromide | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | AZ, NM, UT |
| Drug | CLASS II | rocuronium, 50 mg/, (10 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium 50 mg/ (10 mg/mL) Syringes recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium, 50 mg /, (10 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | ROcuronium Bromide 50 mg/ ( 10 mg/mL) Syringe recalled | New England Life Care | Manufacturing (CGMP) Deviations | Nationwide |