CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl recalled
Pharmedium Services is recalling 2 mcg/mL Fentanyl Citrate and 0.0625% 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-1391-2016
- 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
2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95
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 2K9966 , Lot Number 160390021M , Exp. Date 5/9/2016 ; Service Code 2K9966 , Lot Number 160450151M , Exp. Date 5/15/2016 ; Service Code 2K9966 , Lot Number 160610223M , Exp. Date 5/31/2016 ; Service Code 2K9966 , Lot Number 160660080M , Exp. Date 6/5/2016 ; Service Code 2K9966 , Lot Number 160880210M , Exp. Date 6/27/2016 ; Service Code 2K9966 , Lot Number 160890277M , Exp. Date 6/28/2016 ; Service Code 2K9966 , Lot Number 160910004M , Exp. Date 6/29/2016 ; Service Code 3V8709 , Lot Number 160550119M , Exp. Date 5/19/2016 ; Service Code 3V8709 , Lot Number 160630116M , Exp. Date 5/27/2016 ; Service Code 3V8709 , Lot Number 160750050M , Exp. Date 6/7/2016 ; Service Code 3V8709 , Lot Number 160890054M , Exp. Date 6/21/2016 ; Service Code 3V8724 , Lot Number 160390325M , Exp. Date 5/9/2016 ; Service Code 3V8724 , Lot Number 160600304M , Exp. Date 5/30/2016 ; Service Code 3V8724 , Lot Number 160770031M , Exp. Date 6/15/2016 ; Service Code 3V8724 , Lot Number 160880271M , Exp. Date 6/27/2016 ; Service Code 2H8129 , Lot Number 160540238M , Exp. Date 5/20/2016 ; Service Code 2H8129 , Lot Number 160590104M , Exp. Date 5/25/2016 ; Service Code 2H8129 , Lot Number 160660247M , Exp. Date 6/1/2016 ; Service Code 2H8129 , Lot Number 160730274M , Exp. Date 6/8/2016 ; Service Code 2H8129 , Lot Number 160810226M , Exp. Date 6/16/2016 ; Service Code 2H8129 , Lot Number 160840032M , Exp. Date 6/19/2016 ; Service Code 2H8129 , Lot Number 160940173M , Exp. Date 6/29/2016 ; Service Code 2H8129 , Lot Number 161080115M , Exp. Date 7/13/2016 ; Service Code 2H8132 , Lot Number 160390248M , Exp. Date 5/9/2016 ; Service Code 2H8132 , Lot Number 160460217M , Exp. Date 5/16/2016 ; Service Code 2H8132 , Lot Number 160490227M , Exp. Date 5/19/2016 ; Service Code 2H8132 , Lot Number 160530175M , Exp. Date 5/23/2016 ; Service Code 2H8132 , Lot Number 160600229M , Exp. Date 5/30/2016 ; Service Code 2H8132 , Lot Number 160660244M , Exp. Date 6/5/2016 ; Service Code 2H8132 , Lot Number 160700169M , Exp. Date 6/9/2016 ; Service Code 2H8132 , Lot Number 160750149M , Exp. Date 6/14/2016 ; Service Code 2H8132 , Lot Number 160830147M , Exp. Date 6/22/2016 ; Service Code 2H8132 , Lot Number 160890269M , Exp. Date 6/28/2016 ; Service Code 2H8132 , Lot Number 160940240M , Exp. Date 7/3/2016 ; Service Code 2K8121 , Lot Number 160380131M , Exp. Date 5/8/2016 ; Service Code 2K8121 , Lot Number 160410135M , Exp. Date 5/11/2016 ; Service Code 2K8121 , Lot Number 160490155M , Exp. Date 5/19/2016 ; Service Code 2K8121 , Lot Number 160550154M , Exp. Date 5/25/2016 ; Service Code 2K8121 , Lot Number 160600215M , Exp. Date 5/30/2016 ; Service Code 2K8121 , Lot Number 160660234M , Exp. Date 6/5/2016 ; Service Code 2K8121 , Lot Number 160730257M , Exp. Date 6/12/2016 ; Service Code 2K8121 , Lot Number 160800137M , Exp. Date 6/19/2016 ; Service Code 2K8121 , Lot Number 160830143M , Exp. Date 6/22/2016 ; Service Code 2K8121 , Lot Number 160910135M , Exp. Date 6/30/2016 ; Service Code 2K8121 , Lot Number 160940233M , Exp. Date 7/3/2016 ; Service Code 2K8132 , Lot Number 160420102M , Exp. Date 5/6/2016 ; Service Code 2K8132 , Lot Number 160420214M , Exp. Date 5/6/2016 ; Service Code 2K8132 , Lot Number 160420342M , Exp. Date 5/6/2016 ; Service Code 2K8132 , Lot Number 160450074M , Exp. Date 5/9/2016 ; Service Code 2K8132 , Lot Number 160450075M , Exp. Date 5/9/2016 ; Service Code 2K8132 , Lot Number 160450364M , Exp. Date 5/9/2016 ; Service Code 2K8132 , Lot Number 160470314M , Exp. Date 5/11/2016 ; Service Code 2K8132 , Lot Number 160480039M , Exp. Date 5/12/2016 ; Service Code 2K8132 , Lot Number 160520295M , Exp. Date 5/16/2016 ; Service Code 2K8132 , Lot Number 160530061M , Exp. Date 5/17/2016 ; Service Code 2K8132 , Lot Number 160550332M , Exp. Date 5/19/2016 ; Service Code 2K8132 , Lot Number 160550333M , Exp. Date 5/19/2016 ; Service Code 2K8132 , Lot Number 160590128M , Exp. Date 5/23/2016 ; Service Code 2K8132 , Lot Number 160610345M , Exp. Date 5/25/2016 ; Service Code 2K8132 , Lot Number 160620323M , Exp. Date 5/26/2016 ; Service Code 2K8132 , Lot Number 160630049M , Exp. Date 5/27/2016 ; Service Code 2K8132 , Lot Number 160630311M , Exp. Date 5/27/2016 ; Service Code 2K8132 , Lot Number 160660105M , Exp. Date 5/30/2016 ; Service Code 2K8132 , Lot Number 160670059M , Exp. Date 5/31/2016 ; Service Code 2K8132 , Lot Number 160680062M , Exp. Date 6/1/2016 ; Service Code 2K8132 , Lot Number 160690053M , Exp. Date 6/2/2016 ; Service Code 2K8132 , Lot Number 160700311M , Exp. Date 6/3/2016 ; Service Code 2K8132 , Lot Number 160730118M , Exp. Date 6/6/2016 ; Service Code 2K8132 , Lot Number 160750058M , Exp. Date 6/8/2016 ; Service Code 2K8132 , Lot Number 160760291M , Exp. Date 6/9/2016 ; Service Code 2K8132 , Lot Number 160770324M , Exp. Date 6/10/2016 ; Service Code 2K8132 , Lot Number 160800122M , Exp. Date 6/13/2016 ; Service Code 2K8132 , Lot Number 160810238M , Exp. Date 6/14/2016 ; Service Code 2K8132 , Lot Number 160820044M , Exp. Date 6/15/2016 ; Service Code 2K8132 , Lot Number 160820079M , Exp. Date 6/15/2016 ; Service Code 2K8132 , Lot Number 160820080M , Exp. Date 6/15/2016 ; Service Code 2K8132 , Lot Number 160830059M , Exp. Date 6/16/2016 ; Service Code 2K8132 , Lot Number 160870117M , Exp. Date 6/20/2016 ; Service Code 2K8132 , Lot Number 160870336M , Exp. Date 6/20/2016 ; Service Code 2K8132 , Lot Number 160880064M , Exp. Date 6/21/2016 ; Service Code 2K8132 , Lot Number 160890069M , Exp. Date 6/22/2016 ; Service Code 2K8132 , Lot Number 160890367M , Exp. Date 6/22/2016 ; Service Code 2K8132 , Lot Number 160890368M , Exp. Date 6/22/2016 ; Service Code 2K8132 , Lot Number 160900057M , Exp. Date 6/23/2016 ; Service Code 2K8132 , Lot Number 160910324M , Exp. Date 6/24/2016 ; Service Code 2K8132 , Lot Number 160950330M , Exp. Date 6/28/2016 ; Service Code 2K8132 , Lot Number 160960326M , Exp. Date 6/29/2016 ; Service Code 2K8132 , Lot Number 160970297M , Exp. Date 6/30/2016 ; Service Code 2K8132 , Lot Number 161090001M , Exp. Date 7/11/2016 ; Service Code 2K8639 , Lot Number 160420251M , Exp. Date 5/12/2016 ; Service Code 2K8639 , Lot Number 160490106M , Exp. Date 5/18/2016 ; Service Code 2K8639 , Lot Number 160550111M , Exp. Date 5/24/2016 ; Service Code 2K8639 , Lot Number 160600305M , Exp. Date 5/30/2016 ; Service Code 2K8639 , Lot Number 160730255M , Exp. Date 6/12/2016 ; Service Code 2K8639 , Lot Number 160800207M , Exp. Date 6/19/2016 ; Service Code 2K8639 , Lot Number 160830196M , Exp. Date 6/22/2016 ; Service Code 2K8639 , Lot Number 160900151M , Exp. Date 6/29/2016 ; Service Code 2K8639 , Lot Number 161080236M , Exp. Date 7/17/2016 ; Service Code 2K8862 , Lot Number 160610069M , Exp. Date 5/21/2016 ; Service Code 2K8862 , Lot Number 160630040M , Exp. Date 5/23/2016 ; Service Code 2K8862 , Lot Number 160670182M , Exp. Date 5/28/2016 ; Service Code 2K8862 , Lot Number 160680046M , Exp. Date 5/28/2016 ; Service Code 2K8862 , Lot Number 160800056M , Exp. Date 6/9/2016 ; Service Code 2K8862 , Lot Number 160840030M , Exp. Date 6/13/2016 ; Service Code 2K8862 , Lot Number 160840126M , Exp. Date 6/14/2016 ; Service Code 2K8862 , Lot Number 160870048M , Exp. Date 6/16/2016 ; Service Code 2K8862 , Lot Number 160940149M , Exp. Date 6/24/2016 ; Service Code 2K8862 , Lot Number 160950029C , Exp. Date 6/25/2016 ; Service Code 2K8862 , Lot Number 160960240M , Exp. Date 6/26/2016 ; Service Code 2K8966 , Lot Number 160830024C , Exp. Date 6/13/2016 ; Service Code 2K9121 , Lot Number 160460255M , Exp. Date 5/16/2016 ; Service Code 2K9121 , Lot Number 160600258M , Exp. Date 5/30/2016 ; Service Code 2K9121 , Lot Number 160600259M , Exp. Date 5/30/2016 ; Service Code 2K9121 , Lot Number 160600260M , Exp. Date 5/30/2016 ; Service Code 2K9121 , Lot Number 160750165M , Exp. Date 6/14/2016 ; Service Code 2K9121 , Lot Number 160750166M , Exp. Date 6/14/2016 ; Service Code 2K9132 , Lot Number 160450014C , Exp. Date 5/9/2016 ; Service Code 2K9132 , Lot Number 160520015C , Exp. Date 5/16/2016 ; Service Code 2K9132 , Lot Number 160600001C , Exp. Date 5/23/2016 ; Service Code 2K9132 , Lot Number 160670015C , Exp. Date 5/31/2016 ; Service Code 2K9132 , Lot Number 160730005C , Exp. Date 6/6/2016 ; Service Code 2K9132 , Lot Number 160800021C , Exp. Date 6/13/2016 ; Service Code 2K9132 , Lot Number 160870006C , Exp. Date 6/20/2016 ; Service Code 2K9132 , Lot Number 160940120M , Exp. Date 6/27/2016 ; Service Code 2K9132 , Lot Number 161080116M , Exp. Date 7/11/2016 ; Service Code 2T8862 , Lot Number 160960238M , Exp. Date 5/6/2016 ; Service Code 2T8862 , Lot Number 160970116M , Exp. Date 5/6/2016 ;
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.
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|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
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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 |