Recalls / Class II
Class IID-0443-2023
Product
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
- Affected lot / code info
- Lot #: 2230895, Exp. Date 3/5/2023; 2230911, Exp. Date 3/11/2023; 2230913, Exp. Date 3/18/2023; 2230994, Exp. Date 3/27/2023; 2231006, Exp. Date 4/1/2023; 2231109, Exp. Date 4/19/2023; 2231126, Exp. Date 5/6/2023; 2231134, Exp. Date 5/10/2023; 2231140, Exp. Date 5/14/2023; 2231142, Exp. Date 5/20/2023; 2231156, Exp. Date 5/29/2023; 2231273, Exp. Date 6/3/2023; 2231285, Exp. Date 6/10/2023; 2231299, Exp. Date 6/17/2023; 2231331, Exp. Date 6/26/2023; 2330014, Exp. Date 7/9/2023; 2330025, Exp. Date 7/15/2023
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
- 325,300 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-0443-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.