Drug product
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
D-0745-2022
Product summary
- Event
- Event 89937
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3795 syringes
- Official record key
drug-enforcement:D-0745-2022
Official wording
Reason: 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.
Code information: Lots: 210137-01 BUD: 05/25/2022; 220026-01 BUD: 8/12/2022; 220050-01 BUD: 08/22/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect