CLASS II Drug recall · Reported 26 Dec 2018 · FDA Enforcement Report
Fentanyl Citrate 2 mcg per mL (100 mcg recalled by Pharmedium Services
Pharmedium Services is recalling Fentanyl Citrate 2 mcg per mL (100 mcg per and Ropivacaine HCl 0.1% in Sodium Chloride, distributed nationwide in the US. The recall was initiated on 5 Dec 2018 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-0333-2019
- FDA event ID
- 81730
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Dec 2018
- FDA classified
- 15 Dec 2018
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 5 Dec 2018 | Recall initiated by company | |
| 15 Dec 2018 | Classified by FDA | +10 days |
| 26 Dec 2018 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub-potent
Product as listed by the FDA
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Sub-potent
Which lots are affected?
Lot: 183220013C Exp. 12/19/2018
Where was it sold?
Nationwide in the USA.
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 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 81730This product is part of a recall event; the main page for the event is Fentanyl Citrate 2 mcg per mL (200 mcg recalled by Pharmedium Services.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Fentanyl Citrate 2 mcg per mL (200 mcg recalled by Pharmedium Services | Pharmedium Services | Other | Nationwide |
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 |
Other Fentanyl Per Ml ( Per recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fentanyl Citrate 2 mcg per mL (200 mcg recalled by Pharmedium Services | Pharmedium Services | Other | Nationwide |