Denver Solutions, LLC DBA Leiters Health: Drug Recall
Recall #D-0445-2023 · 02/21/2023
Class II: Risk
Recall Details
- Recall Number
- D-0445-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Denver Solutions, LLC DBA Leiters Health
- Status
- Terminated
- Date Initiated
- 02/21/2023
- Location
- Englewood, CO, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,136 units
Reason for Recall
CGMP DEVIATIONS
Product Description
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Distribution Pattern
Nationwide within the United States including VA or other Government facilities
Other Recalls by Denver Solutions, LLC DBA Leiters Health
- Class II: Risk 03/31/2025
- Class II: Risk 03/31/2025
- Class II: Risk 03/31/2025
- Class II: Risk 03/31/2025
- Class II: Risk 03/31/2025
View all recalls by Denver Solutions, LLC DBA Leiters Health →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.