Recalls / Class II
Class IID-0445-2023
Product
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
- Affected lot / code info
- Lot #: 2231026, Exp. Date 2/23/2023; 2231051, Exp. Date 3/11/2023; 2231156, Exp. Date 5/29/2023; 2231163, Exp. Date 3/26/2023; 223130, Exp. Date 4 5/7/2023; 2231308, Exp. Date 5/11/2023
Why it was recalled
CGMP DEVIATIONS
Recalling firm
- Firm
- Denver Solutions, LLC DBA Leiters Health
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 13796 Compark Blvd, Englewood, Colorado 80112-7145
Distribution
- Quantity
- 8,136 units
- Distribution pattern
- Nationwide within the United States including VA or other Government facilities
Timeline
- Recall initiated
- 2023-02-21
- FDA classified
- 2023-03-07
- Posted by FDA
- 2023-03-15
- Terminated
- 2024-01-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0445-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.