CLASS I Drug recall · Reported 24 Feb 2016 · FDA Enforcement Report
fentaNYL Citrate, Preservative Free recalled by Pharmedium Services
Pharmedium Services is recalling fentaNYL Citrate, Preservative Free, 10 mcg per In 0.9% Sodium Chloride Total Volume For, distributed in 7 states. The recall was initiated on 13 Jan 2015 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-724-2016
- FDA event ID
- 72380
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 13 Jan 2015
- FDA classified
- 18 Feb 2016
- Reported
- 24 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 13 Jan 2015 | Recall initiated by company | |
| 18 Feb 2016 | Classified by FDA | +401 days |
| 24 Feb 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
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, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium
Where it was distributed
Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: 15002250M, Exp 04-02-2015
Where was it sold?
Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.
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
1 other product · FDA event 72380| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | fentaNYL Citrate, Preservative Free recalled by Pharmedium Services | Pharmedium Services | Potency & Assay | 7 states |
More recalls from Pharmedium Services
All 291| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |