Reported Apr 13, 2022 · Terminated
23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITEDOSE, 503B…
The Ritedose Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Ritedose Corporation · 1 Technology Cir · Columbia, SC · 29203-9591
Is this the product you have?
23.4% Sodium Chloride Injection120 mEq per 30 mL (4 mEq/mL)50 mL prefilled syringRx OnlyRITEDOSE503B Outsourcing FacilityA Division of the RITEDOSE Corporation1 Technology CircleColumbiaSC 292031-866-994-4670
- NDC
65302-509-30barcode N (01) 003 65302 50930 0
- Lot codes and dates
- Lots210137-01
- BUD
05/25/2022220026-01
- BUD
8/12/2022220050-01
- BUD08/22/2022
- Amount recalled
- 3795 syringes
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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