RecallDepth
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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