Reported Nov 1, 2023 · Terminated
VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796…
Denver Solutions, LLC dba Leiters Health
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Denver Solutions, LLC DBA Leiters Health · 13796 Compark Blvd · Englewood, CO · 80112-7145
Is this the product you have?
- VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.
- Lot codes and dates
Lot#: 2330792Exp. 12/17/232330801Exp. 12/26/23233082110/15/232330823Exp. 10/21/232330825Exp. 10/27/232330846Exp. 10/28/232330847Exp. 11/03/23233085611/17/232330858Exp. 12/03/23233086012/15/232330866Exp. 12/29/232331053Exp. 01/13/24
- Amount recalled
- 25,908 IV bags
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Labeling: Not Elsewhere Classified
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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