Sodium Chloride Injection with Incorrect Barcode Labeling Recalled Nationwide
Ritedose is recalling 3,795 prefilled syringes of sodium chloride injection nationwide. The barcodes incorrectly identify the product as rocuronium bromide, creating a medication identification risk in healthcare settings.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall involving labeling/barcode errors with no reported illnesses or injuries. The hazard is theoretical; per the severity rubric, this qualifies as a minor labeling error without confirmed adverse events.
Plain-English summary
The Ritedose Corporation is recalling 23.4% Sodium Chloride Injection, 120 mEq per 30 mL in 50 mL prefilled syringes (NDC: 65302-509-30). The product is a sterile injectable solution distributed nationwide.
The recall is due to incorrect barcode labeling on affected syringes. The barcodes identify the product as rocuronium bromide injection (a neuromuscular blocking agent) instead of sodium chloride injection. This discrepancy between the barcode label and the actual product contents could result in medication identification errors in healthcare settings.
Affected lot numbers are 210137-01 (BUD 05/25/2022), 220026-01 (BUD 8/12/2022), and 220050-01 (BUD 08/22/2022). Healthcare facilities and practitioners who have received these syringes should verify actual product contents against barcode labels and contact Ritedose at 1-866-994-4670 or 1 Technology Circle, Columbia, SC 29203 with questions.
The recalled product
- Product
- 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…
- Manufacturer
- The Ritedose Corporation
- Category
- Drug — Injectable Solution
- Affected units
- 3,795
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots: 210137-01 BUD: 05/25/2022
- 220026-01 BUD: 8/12/2022
- 220050-01 BUD: 08/22/2022
Distribution
Distributed nationwide across the United States.
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