Drug recall
Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter…
FDA recall event 93178 · Class III · Denver Solutions, LLC DBA Leiters Health
Key facts
| Event ID | 93178 |
|---|---|
| Recall numbers | D-0070-2024, D-0071-2024, D-0072-2024 |
| Recalling firm | Denver Solutions, LLC DBA Leiters Health |
| Product type | Drugs |
| Products | 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, VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68., VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Labeling: Not Elsewhere Classified |
| Initiation date | Oct 4, 2023 |
| Report date | Nov 1, 2023 |
| Termination date | Aug 15, 2024 |
| City | Englewood |
| State | CO |
| Country | United States |
| FEI number | 3013438582 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: