Reported Mar 15, 2023 · Terminated
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC…
Denver Solutions, LLC dba Leiters Health
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Denver Solutions, LLC DBA Leiters Health · 13796 Compark Blvd · Englewood, CO · 80112-7145
Is this the product you have?
- Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
- Lot codes and dates
Lot #: 2230895Exp. Date 3/5/20232230911Exp. Date 3/11/20232230913Exp. Date 3/18/20232230994Exp. Date 3/27/20232231006Exp. Date 4/1/20232231109Exp. Date 4/19/20232231126Exp. Date 5/6/20232231134Exp. Date 5/10/20232231140Exp. Date 5/14/20232231142Exp. Date 5/20/20232231156Exp. Date 5/29/20232231273Exp. Date 6/3/20232231285Exp. Date 6/10/20232231299Exp. Date 6/17/20232231331Exp. Date 6/26/20232330014Exp. Date 7/9/20232330025Exp. Date 7/15/2023
- Amount recalled
- 325,300 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- VA
Why it was recalled
CGMP DEVIATIONS
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Denver Solutions, LLC dba Leiters Health recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.