D-0745-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 13, 2022
- Initiation Date
- April 1, 2022
- Termination Date
- December 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3795 syringes
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
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: 210137-01 BUD: 05/25/2022; 220026-01 BUD: 8/12/2022; 220050-01 BUD: 08/22/2022