CLASS I ONGOING Drug recall · Reported 7 Feb 2024 · FDA Enforcement Report
FentaNYL citrate PF, 2500 mcg per 9% Sodium Chloride (10 mcg per mL) recalled
Denver Solutions is recalling FentaNYL citrate PF, 2500 mcg per 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
- Foreign Material
- 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.
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
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
Is FentaNYL citrate PF, 2500 mcg per 9% Sodium Chloride (10 mcg per mL) recalled?
Yes. Denver Solutions recalled FentaNYL citrate PF, 2500 mcg per 9% Sodium Chloride (10 mcg per mL) on 28 Dec 2023. The recall is Class I and its status is Ongoing. Recall number D-0278-2024.
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 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
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|---|---|---|---|---|---|
| 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 |