FDAFDA · Food and drugs·Recall number D-0443-2023
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
Published March 15, 2023 · Recall initiated: February 21, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP DEVIATIONS
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Distributor
- Nationwide within the United States including VA or other Government facilities
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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