Class III
Terminated
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
This recall has been terminated (originally issued April 13, 2022).
- Company
- The Ritedose Corporation
- Recall Initiated
- April 1, 2022
- Posted
- April 13, 2022
- Recall Number
- D-0745-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3795 syringes
- Firm Location
- Columbia, SC, United States
- Official Source
- View on FDA website ↗
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
Nationwide in the USA
Lot / Code Info
Lots: 210137-01 BUD: 05/25/2022; 220026-01 BUD: 8/12/2022; 220050-01 BUD: 08/22/2022
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