PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: November 1, 2023 Initiated: October 4, 2023 #D-0070-2024

Product Description

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

Details

Units Affected
6,276 IV bags
Distribution
USA Nationwide
Location
Englewood, CO

Frequently Asked Questions

What product was recalled?
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. Recalled by Denver Solutions, LLC DBA Leiters Health. Units affected: 6,276 IV bags.
Why was this product recalled?
Labeling: Not Elsewhere Classified
Which agency issued this recall?
This recall was issued by the FDA Drug on November 1, 2023. Severity: Low. Recall number: D-0070-2024.