← FDA ENFORCEMENT
D-0070-2024Class III

Denver Solutions, LLC DBA Leiters Health

Recalling firm
Denver Solutions, LLC DBA Leiters Health
Product type
Drug
Status
Terminated
Report date
2023-11-01
Distribution
USA Nationwide
Firm state
CO
Product quantity
6,276 IV bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Labeling: Not Elsewhere Classified

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.