Class II
Terminated
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
This recall has been terminated (originally issued January 18, 2023).
- Recall Initiated
- January 6, 2023
- Posted
- January 18, 2023
- Recall Number
- D-0099-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 38,830 syringes
- Firm Location
- West Columbia, SC, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA.
Lot / Code Info
Lot: RC2011A, Exp. 2/22/2023
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