The Ritedose Corporation: Drug Recall

Recall #D-0745-2022 · 04/01/2022

Class III: Low Risk

Recall Details

Recall Number
D-0745-2022
Classification
Class III
Product Type
Drug
Recalling Firm
The Ritedose Corporation
Status
Terminated
Date Initiated
04/01/2022
Location
Columbia, SC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3795 syringes

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.

Product Description

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

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.