Rocuronium Bromide Injection recall: Sterility Concern
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…
Why was Rocuronium Bromide Injection recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: RC2011A, Exp. 2/22/2023
- 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…
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Quantity
- 38,830 syringes
- Distribution
- Nationwide in the USA.
- Recall date
- January 18, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)