Denver Solutions, LLC DBA Leiters Health 2023-03-15 Health serious FDA
Health · FDA · Recall #FDA-D-0442-2023
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796… Recall
Issued March 15, 2023 · Denver Solutions, LLC DBA Leiters Health
In March 2023, Denver Solutions, LLC DBA Leiters Health recalled the Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP DEVIATIONS
What you should do
- 1 Stop using Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Denver Solutions, LLC DBA Leiters Health to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Denver Solutions, LLC DBA Leiters Health
- Category
- Health
- Recall date
- March 15, 2023
- Units affected
- Not reported
- Sold at
- Nationwide within the United States including VA or other Government facilities
- Recall number
- FDA-D-0442-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Denver Solutions, LLC DBA Leiters Health has 12 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.