FDA recall D-0070-2024
Denver Solutions, LLC DBA Leiters Health · Class III · drug
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
Reason for recall
Labeling: Not Elsewhere Classified
Distribution
USA Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2023-10-04
- Report date
- 2023-11-01
- Termination date
- 2024-08-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Englewood, CO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0070-2024