Recalls / Class III
Class IIID-0745-2022
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
- Affected lot / code info
- Lots: 210137-01 BUD: 05/25/2022; 220026-01 BUD: 8/12/2022; 220050-01 BUD: 08/22/2022
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.
Recalling firm
- Firm
- The Ritedose Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Technology Cir, Columbia, South Carolina 29203-9591
Distribution
- Quantity
- 3795 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-04-01
- FDA classified
- 2022-04-05
- Posted by FDA
- 2022-04-13
- Terminated
- 2022-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0745-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.