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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ritedose Sodium Chloride Injection Recalled for Incorrect Barcode Labeling

Agency Publication Date: April 4, 2022
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Summary

The Ritedose Corporation is recalling 3,795 syringes of Ritedose 23.4% Sodium Chloride Injection because the barcode on the syringe label is incorrect. The barcode mistakenly identifies the product as rocuronium bromide injection, a muscle relaxant, instead of sodium chloride. While the human-readable text on the label is correct, scanning the barcode could lead to medication errors. No incidents or injuries have been reported to date.

Risk

If healthcare providers rely on scanning the incorrect barcode for medication administration, they may inadvertently administer sodium chloride when rocuronium bromide was intended, or vice versa, leading to inappropriate treatment and potential patient harm.

What You Should Do

  1. This recall affects 50 mL prefilled syringes of 23.4% Sodium Chloride Injection (120 mEq per 30 mL) sold under the RITEDOSE brand from a 503B Outsourcing Facility.
  2. Identify affected products by checking for NDC 65302-509-30 and the following lot numbers: 210137-01 (BUD: 05/25/2022), 220026-01 (BUD: 8/12/2022), or 220050-01 (BUD: 08/22/2022).
  3. Stop using the recalled product immediately.
  4. Contact The Ritedose Corporation at 1-866-994-4670 to arrange for the return of any remaining syringes.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: 23.4% Sodium Chloride Injection (50 mL prefilled syringe)by RITEDOSE
Variants: 120 mEq per 30 mL (4 mEq/mL), Rx Only
Lot Numbers:
210137-01 (BUD: 05/25/2022)
220026-01 (BUD: 8/12/2022)
220050-01 (BUD: 08/22/2022)
NDC:
65302-509-30
GTIN:
00365302509300

The product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89937
Status: Resolved
Manufacturer: The Ritedose Corporation
Sold By: 503B Outsourcing Facility; Hospitals; Surgical Centers
Manufactured In: United States
Units Affected: 3795 syringes
Distributed To: Nationwide
Agency Last Updated: April 5, 2022

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.