← FDA ENFORCEMENT
D-0071-2024Class 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
33,480 IV Bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Labeling: Not Elsewhere Classified

Product description

VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.

Code / lot info

Lot#: 2330781, Exp. 10/19/23; 2330791, Exp. 10/29/23; 2330795, Exp. 11/02/23; 2330800, Exp. 11/09/23; 2330807, Exp. 11/11/23; 2330812, Exp. 11/16/23; 2330816, Exp. 11/19/23; 2330822, 10/20/23; 2330897,11/23/23; 2330899, 11/25/23; 2330901, 11/26/23; 2330918, 11/30/23; 2330943, 01/12/24; 2331050, 01/14/24; 2331064, 01/21/24; 2331102, Exp. 01/25/24.

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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.