Severity
Low
FDA Drug recall · Reported November 1, 2023
Labeling: Not Elsewhere Classified
Denver Solutions, LLC DBA Leiters Health recalled Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per m… - a low-severity action.
Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per m… was recalled by Denver Solutions, LLC DBA Leiters Health in November 1, 2023. Reason: Labeling: Not Elsewhere Classified. Check the official notice for the remedy. Verify recall #D-0070-2024 with the FDA Drug before acting.
The recall
Denver Solutions, LLC DBA Leiters Health issued this low-severity FDA Drug recall-Labeling: Not Elsewhere Classified.
Sourced from official FDA Drug enforcement records. Verify recall #D-0070-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0070-2024) was formally reported on November 1, 2023, with the manufacturer initiating the action on October 4, 2023. It is classified under Low severity (Class III), with a current status of Terminated. Denver Solutions, LLC DBA Leiters Health is listed as the recalling firm, operating out of Englewood, CO. Federal records list the affected scope as 6,276 IV bags.
The documented reason for this recall is: Labeling: Not Elsewhere Classified Distribution data in the federal record shows the product reached: USA Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
6,276 IV bags
Related Recalls
6
5 from same agency
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
Labeling: Not Elsewhere Classified
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0070-2024 |
| Date reported | November 1, 2023 |
| Date initiated | October 4, 2023 |
| Recalling firm | Denver Solutions, LLC DBA Leiters Health |
| Firm location | Englewood, CO |
| Affected scope | 6,276 IV bags |
| Distribution | USA Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Llorens Pharmaceuticals International Division, Inc. · 2026-05-27
Safecor Health, LLC · 2026-05-27
IntegraDose Compounding Services LLC · 2026-05-27
Lupin Pharmaceuticals Inc. · 2026-05-27
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported November 1, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.