FDA-Drug2023-11-01Class III

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

Denver Solutions, LLC DBA Leiters Health
Hazard

Labeling: Not Elsewhere Classified

Sold states
USA Nationwide
Affected count
6,276 IV bags
Manufactured in
13796 Compark Blvd, N/A, Englewood, CO, United States
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0070-2024

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