CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recalled
Pharmedium Services is recalling 4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium, distributed nationwide in the US. The recall was initiated on 5 May 2016 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-1419-2016
- FDA event ID
- 74057
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 May 2016
- FDA classified
- 16 Jul 2016
- Reported
- 27 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 5 May 2016 | Recall initiated by company | |
| 16 Jul 2016 | Classified by FDA | +72 days |
| 27 Jul 2016 | 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
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Product as listed by the FDA
4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Which lots are affected?
Service Code 2H8267 , Lot Number 160630024M , Exp. Date 5/28/2016 ; Service Code 2K8128 , Lot Number 160490252M , Exp. Date 5/13/2016 ; Service Code 2K8128 , Lot Number 160530274M , Exp. Date 5/17/2016 ; Service Code 2K8128 , Lot Number 160600213M , Exp. Date 5/24/2016 ; Service Code 2K8128 , Lot Number 160660184M , Exp. Date 5/30/2016 ; Service Code 2K8128 , Lot Number 160730236M , Exp. Date 6/6/2016 ; Service Code 2K8128 , Lot Number 160810218M , Exp. Date 6/14/2016 ; Service Code 2K8128 , Lot Number 160820186M , Exp. Date 6/15/2016 ; Service Code 2K8128 , Lot Number 160940172M , Exp. Date 6/27/2016 ; Service Code 2K8267 , Lot Number 160450259M , Exp. Date 5/15/2016 ; Service Code 2K8267 , Lot Number 160540156M , Exp. Date 5/24/2016 ; Service Code 2K8267 , Lot Number 160600323M , Exp. Date 5/30/2016 ; Service Code 2K8267 , Lot Number 160660257M , Exp. Date 6/5/2016 ; Service Code 2K8267 , Lot Number 160730258M , Exp. Date 6/12/2016 ; Service Code 2K8267 , Lot Number 160770130M , Exp. Date 6/16/2016 ; Service Code 2K8267 , Lot Number 160840132M , Exp. Date 6/23/2016 ; Service Code 2K8267 , Lot Number 160900007M , Exp. Date 6/28/2016 ; Service Code 2K8267 , Lot Number 160970143M , Exp. Date 7/6/2016 ; Service Code 2K8267 , Lot Number 161080249M , Exp. Date 7/17/2016 ; Service Code 2K8638 , Lot Number 160410229M , Exp. Date 5/11/2016 ; Service Code 2K8638 , Lot Number 160420200M , Exp. Date 5/12/2016 ; Service Code 2K8638 , Lot Number 160460214M , Exp. Date 5/16/2016 ; Service Code 2K8638 , Lot Number 160480210M , Exp. Date 5/17/2016 ; Service Code 2K8638 , Lot Number 160490254M , Exp. Date 5/19/2016 ; Service Code 2K8638 , Lot Number 160490255M , Exp. Date 5/19/2016 ; Service Code 2K8638 , Lot Number 160520127M , Exp. Date 5/22/2016 ; Service Code 2K8638 , Lot Number 160600310M , Exp. Date 5/30/2016 ; Service Code 2K8638 , Lot Number 160630164M , Exp. Date 6/2/2016 ; Service Code 2K8638 , Lot Number 160670272M , Exp. Date 6/6/2016 ; Service Code 2K8638 , Lot Number 160750259M , Exp. Date 6/14/2016 ; Service Code 2K8638 , Lot Number 160770264M , Exp. Date 6/16/2016 ; Service Code 2K8638 , Lot Number 160840238M , Exp. Date 6/23/2016 ; Service Code 2K8638 , Lot Number 160870197M , Exp. Date 6/26/2016 ; Service Code 2K8638 , Lot Number 160950189M , Exp. Date 7/4/2016 ; Service Code 2K8983 , Lot Number 160530047C , Exp. Date 5/14/2016 ; Service Code 2K8983 , Lot Number 160740088C , Exp. Date 6/4/2016 ; Service Code 2K8983 , Lot Number 160880066C , Exp. Date 6/18/2016 ; Service Code 2K8983 , Lot Number 160970040C , Exp. Date 6/27/2016 ;
Where was it sold?
Nationwide
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
74 other products · FDA event 74057This product is part of a recall event; the main page for the event is 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl recalled.
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 recalls
All 248| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL Citrate, 1,000 mcg recalled by OurPharma | OurPharma | Other | Nationwide |
| Drug | CLASS II | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, CII recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |