CLASS II Drug recall · Reported 15 Mar 2023 · FDA Enforcement Report
Phenylephrine HCl 20 mg (80 mcg/mL) added to 9% Sodium Chloride IV recalled
Denver Solutions is recalling Phenylephrine HCl 20 mg (80 mcg/mL) added to 9% Sodium Chloride IV, distributed nationwide in the US. The recall was initiated on 21 Feb 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0445-2023
- FDA event ID
- 91762
- Recalling firm
- Denver Solutions, Englewood, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Feb 2023
- FDA classified
- 7 Mar 2023
- Reported
- 15 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Drug class
- Cold & Cough Medicine
Timeline
| 21 Feb 2023 | Recall initiated by company | |
| 7 Mar 2023 | Classified by FDA | +14 days |
| 15 Mar 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP DEVIATIONS
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Where it was distributed
Nationwide within the United States including VA or other Government facilities
Questions about this recall
Is Phenylephrine HCl 20 mg (80 mcg/mL) added to 9% Sodium Chloride IV recalled?
Yes. Denver Solutions recalled Phenylephrine HCl 20 mg (80 mcg/mL) added to 9% Sodium Chloride IV on 21 Feb 2023. The recall is Class II and its status is Terminated. Recall number D-0445-2023.
Why was it recalled?
CGMP DEVIATIONS
Which lots are affected?
Lot #: 2231026, Exp. Date 2/23/2023; 2231051, Exp. Date 3/11/2023; 2231156, Exp. Date 5/29/2023; 2231163, Exp. Date 3/26/2023; 223130, Exp. Date 4 5/7/2023; 2231308, Exp. Date 5/11/2023
Where was it sold?
Nationwide within the United States including VA or other Government facilities
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Denver Solutions
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PHENYLephrine HCl in 9% Sodium Chloride, 5 mg recalled | Denver Solutions | Foreign Material | Nationwide |
| Drug | CLASS II | Ketamine HCl 50mg per (10 mg per mL) Single Dose Syringe recalled | Denver Solutions | Foreign Material | Nationwide |
| Drug | CLASS II | Glycopyrrolate, 1mg per, 2 mg/mL), Single Dose syringe recalled | Denver Solutions | Foreign Material | Nationwide |
| Drug | CLASS II | dexmedeTOMIDine HCl PF, in 9% Sodium Chloride, 20 mcg recalled | Denver Solutions | Foreign Material | Nationwide |
| Drug | CLASS II | Rocuronium Bromide 50 mg per (10mg per mL) Single Dose Syringe recalled | Denver Solutions | Foreign Material | Nationwide |