Recalls / Class II
Class IID-0444-2023
Product
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
- Affected lot / code info
- Lot #: 2231017, Exp. Date 3/12/2023
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
- 1212 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-0444-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.