Recalls / Class III
Class IIID-0072-2024
Product
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.
- Affected lot / code info
- Lot#: 2330792, Exp. 12/17/23; 2330801, Exp. 12/26/23; 2330821, 10/15/23; 2330823, Exp. 10/21/23; 2330825, Exp. 10/27/23; 2330846, Exp. 10/28/23; 2330847, Exp. 11/03/23; 2330856, 11/17/23; 2330858, Exp. 12/03/23; 2330860, 12/15/23; 2330866, Exp. 12/29/23; 2331053, Exp. 01/13/24.
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
- 25,908 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-0072-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.