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Recall Observatory FDA recall evidence

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

D-0070-2024

October 04, 2023

Class III

Product summary

Firm
Denver Solutions, LLC DBA Leiters Health
Event
Event 93178
Status
Terminated
Classification
Class III
Quantity
6,276 IV bags
Official record key
drug-enforcement:D-0070-2024

Official wording

Reason: Labeling: Not Elsewhere Classified

Code information: Lot#: 2330956, Exp. 10/23/2023; 2330964, Exp. 10/24/2023; 2331014, Exp. 11/6/2023; 2331033, Exp. 11/8/2023

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Not Elsewhere Classified