Why it was recalled
Lack of Assurance of Sterility
Product description
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
Lot numbers, UPCs & expiration codes
Lot: RC2011A, Exp. 2/22/2023
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0099-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 6, 2023
- FDA report date
- Jan 18, 2023
- Quantity
- 38,830 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Sterile Compounding Center LLC
Original FDA data
Every field from FDA enforcement report D-0099-2023, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 91450
- Address
- 4500 12th Street Ext
- Code information
- Lot: RC2011A, Exp. 2/22/2023
- Postal code
- 29172-3025
- Report date
- Jan 18, 2023
- Product type
- Drugs
- Recall number
- D-0099-2023
- Classification
- Class II
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Product quantity
- 38,830 syringes
- Termination date
- Sep 24, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jan 6, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 9, 2023