Rocuronium Bromide Pre-Filled Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection syringes nationwide due to lack of assurance of sterility. Approximately 6,340 syringes from lot RC2003B (expiration August 28, 2022) 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 an FDA Class II recall of an injectable medication with stated lack of sterility assurance. While no illnesses or injuries have been reported, injectable products with unconfirmed sterility status represent a significant potential risk of harm. This is a risk-of-harm product without reported illness, consistent with High severity.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Rocuronium Bromide Injection (50 mg/5 mL), supplied as pre-filled syringes. The affected lot is RC2003B with an expiration date of August 28, 2022. Approximately 6,340 syringes were distributed nationwide.
The recall was initiated due to lack of assurance of sterility. For injectable products, sterility is a critical safety requirement that must be maintained throughout the product's shelf life.
The syringes were distributed nationwide. Recipients of this product should review their inventory for lot RC2003B and contact Nephron Sterile Compounding Center LLC or the FDA for guidance on product replacement or proper handling.
The recalled product
- Product
- Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, 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 Medication
- Hazard
- sterility-assurance
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 (2)
- Lot: RC2003B
- Exp. 8/28/2022
Distribution
Distributed nationwide across the United States.
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