Recalls / Class III
Class IIID-0071-2024
Product
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.
- Affected lot / code 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.
Why it was recalled
Labeling: Not Elsewhere Classified
Recalling firm
- Firm
- Denver Solutions, LLC DBA Leiters Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 13796 Compark Blvd, N/A, Englewood, Colorado 80112-7145
Distribution
- Quantity
- 33,480 IV Bags
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2023-10-04
- FDA classified
- 2023-10-26
- Posted by FDA
- 2023-11-01
- Terminated
- 2024-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0071-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.