CLASS I ONGOING Drug recall · Reported 7 Feb 2024 · FDA Enforcement Report
FentaNYL citrate PF, 2500 mcg per 0.9% Sodium Chloride recalled
Denver Solutions is recalling FentaNYL citrate PF, 2500 mcg per 0.9% Sodium Chloride (10 mcg per mL), distributed nationwide in the US. The recall was initiated on 28 Dec 2023 and the FDA has classified it as Class I.
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-0278-2024
- FDA event ID
- 93710
- Recalling firm
- Denver Solutions, Englewood, CO
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 28 Dec 2023
- FDA classified
- 29 Jan 2024
- Reported
- 7 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 28 Dec 2023 | Recall initiated by company | |
| 29 Jan 2024 | Classified by FDA | +32 days |
| 7 Feb 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Which lots are affected?
Lot #: 2330988, Exp. Date 01/31/2024; 2331058, Exp. Date 02/18/2024; 2331150, Exp. Date 03/10/2024; 2331231, Exp. Date 03/24/2024; 2331289, Exp. Date 03/30/2024.
Where was it sold?
Nationwide within the United States
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 93710This product is part of a recall event; the main page for the event is VANCOmycin HCl PF added to 0.9% Sodium Chloride IV recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | VANCOmycin HCl PF added to 0.9% Sodium Chloride IV recalled | Denver Solutions | Potency & Assay | Nationwide | |
| CLASS I | FentaNYL citrate PF, 1000 mcg per 0.9% Sodium Chloride recalled | Denver Solutions | Potency & Assay | Nationwide | |
| CLASS I | VANCOmycin HCl PF added to 0.9% Sodium Chloride IV recalled | Denver Solutions | Potency & Assay | Nationwide | |
| CLASS I | PHENYLephrine HCl 20 mg per 0.9% Sodium Chloride (80 mcg per mL) recalled | Denver Solutions | Potency & Assay | Nationwide | |
| CLASS I | PHENYLephrine HCl 40 mg per 0.9% Sodium Chloride (160 mcg per mL) recalled | Denver Solutions | Potency & Assay | Nationwide |
More recalls from Denver Solutions
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | Ketamine HCl 50mg per (10 mg per mL) Single Dose Syringe recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | Glycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | Rocuronium Bromide 50 mg per (10mg per mL) Single Dose Syringe recalled | Denver Solutions | Sterility | Nationwide |
Other Fentanyl Pf recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | FentaNYL Citrate PF, 500mcg/ (10mcg/mL) in Nacl recalled by STAQ Pharma | Staq Pharma | Other | Nationwide |
| Drug | CLASS II | fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma | QuVa Pharma | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma | QuVa Pharma | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma | QuVa Pharma | Sterility | Nationwide |
| Drug | CLASS I | FentaNYL citrate PF, 1000 mcg per 0.9% Sodium Chloride recalled | Denver Solutions | Potency & Assay | Nationwide |