Oxytocin IV Bags Recalled Due to Labeling Defect
Denver Solutions recalls 6,276 IV bags of oxytocin due to a labeling defect. The product was distributed nationwide to healthcare facilities.
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 with no reported illnesses or injuries. Per the severity rubric, minor labeling errors are classified as Moderate (score 2), and the absence of reported harm supports this rating.
Plain-English summary
Denver Solutions, LLC DBA Leiters Health is recalling 6,276 IV bags containing oxytocin synthetic (30 Units in 0.9% Sodium Chloride 500mL) due to a labeling issue. The product is supplied as a compounded pharmaceutical, Rx only, and was distributed nationwide.
The FDA classified this recall under the category "Labeling: Not Elsewhere Classified." The specific nature of the labeling defect is not detailed in the recall notice.
Healthcare facilities and distributors that received this product should quarantine remaining stock and cease use. The affected lot numbers are: 2330956 (Exp. 10/23/2023), 2330964 (Exp. 10/24/2023), 2331014 (Exp. 11/6/2023), and 2331033 (Exp. 11/8/2023). Consumers or healthcare providers with questions should contact Denver Solutions for further guidance.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Hazard
- Affected units
- 6,276
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 (8)
- Lot#: 2330956
- Exp. 10/23/2023
- 2330964
- Exp. 10/24/2023
- 2331014
- Exp. 11/6/2023
- 2331033
- Exp. 11/8/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Denver Solutions, LLC DBA Leiters Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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