Why it was recalled
Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
Product description
23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITEDOSE, 503B Outsourcing Facility, A Division of the RITEDOSE Corporation, 1 Technology Circle, Columbia, SC 29203, 1-866-994-4670, NDC: 65302-509-30, barcode N (01) 003 65302 50930 0
Lot numbers, UPCs & expiration codes
Lots: 210137-01 BUD: 05/25/2022; 220026-01 BUD: 8/12/2022; 220050-01 BUD: 08/22/2022
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-0745-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 1, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- 3795 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Ritedose Corporation
Original FDA data
Every field from FDA enforcement report D-0745-2022, exactly as published.
Show all FDA fields
- City
- Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 89937
- Address
- 1 Technology Cir
- Code information
- Lots: 210137-01 BUD: 05/25/2022; 220026-01 BUD: 8/12/2022; 220050-01 BUD: 08/22/2022
- Postal code
- 29203-9591
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0745-2022
- Classification
- Class III
- Recalling firm
- The Ritedose Corporation
- Product quantity
- 3795 syringes
- Termination date
- Dec 2, 2022
- Reason for recall
- Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITEDOSE, 503B Outsourcing Facility, A Division of the RITEDOSE Corporation, 1 Technology Circle, Columbia, SC 29203, 1-866-994-4670, NDC: 65302-509-30, barcode N (01) 003 65302 50930 0
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 1, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 5, 2022