CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled
Pharmedium Services is recalling 5 mcg/mL Fentanyl Citrate and 0.125% 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-1426-2016
- 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
5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
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 2H8139 , Lot Number 160420171M , Exp. Date 5/12/2016 ; Service Code 2H8139 , Lot Number 160460111M , Exp. Date 5/16/2016 ; Service Code 2H8139 , Lot Number 160490001M , Exp. Date 5/18/2016 ; Service Code 2H8139 , Lot Number 160530289M , Exp. Date 5/23/2016 ; Service Code 2H8139 , Lot Number 160560215M , Exp. Date 5/26/2016 ; Service Code 2H8139 , Lot Number 160590055M , Exp. Date 5/29/2016 ; Service Code 2H8139 , Lot Number 160600232M , Exp. Date 5/30/2016 ; Service Code 2H8139 , Lot Number 160610189M , Exp. Date 5/31/2016 ; Service Code 2H8139 , Lot Number 160670159M , Exp. Date 6/6/2016 ; Service Code 2H8139 , Lot Number 160740151M , Exp. Date 6/13/2016 ; Service Code 2H8139 , Lot Number 160770172M , Exp. Date 6/16/2016 ; Service Code 2H8139 , Lot Number 160800069M , Exp. Date 6/18/2016 ; Service Code 2H8139 , Lot Number 160810208M , Exp. Date 6/20/2016 ; Service Code 2H8139 , Lot Number 160900168M , Exp. Date 6/29/2016 ; Service Code 2H8139 , Lot Number 160960158M , Exp. Date 7/5/2016 ; Service Code 2H8139 , Lot Number 161080229M , Exp. Date 7/17/2016 ; Service Code 2H8140 , Lot Number 160450212M , Exp. Date 5/11/2016 ; Service Code 2H8140 , Lot Number 160550237M , Exp. Date 5/21/2016 ; Service Code 2H8140 , Lot Number 160660222M , Exp. Date 6/1/2016 ; Service Code 2H8140 , Lot Number 160670248M , Exp. Date 6/2/2016 ; Service Code 2H8140 , Lot Number 160700215M , Exp. Date 6/5/2016 ; Service Code 2H8140 , Lot Number 160870227M , Exp. Date 6/22/2016 ; Service Code 2H8140 , Lot Number 160880150M , Exp. Date 6/23/2016 ; Service Code 2H8140 , Lot Number 160940208M , Exp. Date 6/29/2016 ; Service Code 2H8140 , Lot Number 161080214M , Exp. Date 7/13/2016 ; Service Code 2K8139 , Lot Number 160450047M , Exp. Date 5/9/2016 ; Service Code 2K8139 , Lot Number 160590188M , Exp. Date 5/23/2016 ; Service Code 2K8139 , Lot Number 160610248M , Exp. Date 5/25/2016 ; Service Code 2K8139 , Lot Number 160730263M , Exp. Date 6/6/2016 ; Service Code 2K8139 , Lot Number 160770133M , Exp. Date 6/10/2016 ; Service Code 2K8139 , Lot Number 160820143M , Exp. Date 6/15/2016 ; Service Code 2K8139 , Lot Number 160880151M , Exp. Date 6/21/2016 ; Service Code 2K8139 , Lot Number 160910235M , Exp. Date 6/24/2016 ; Service Code 2K8247 , Lot Number 160400202M , Exp. Date 5/10/2016 ; Service Code 2K8247 , Lot Number 160460151M , Exp. Date 5/16/2016 ; Service Code 2K8247 , Lot Number 160470188M , Exp. Date 5/17/2016 ; Service Code 2K8247 , Lot Number 160590141M , Exp. Date 5/29/2016 ; Service Code 2K8247 , Lot Number 160620192M , Exp. Date 6/1/2016 ; Service Code 2K8247 , Lot Number 160700158M , Exp. Date 6/9/2016 ; Service Code 2K8247 , Lot Number 160820178M , Exp. Date 6/21/2016 ; Service Code 2K8247 , Lot Number 160840216M , Exp. Date 6/23/2016 ; Service Code 2K8247 , Lot Number 160910142M , Exp. Date 6/30/2016 ; Service Code 2K8247 , Lot Number 160940212M , Exp. Date 7/3/2016 ; Service Code 2K8247 , Lot Number 161080223M , Exp. Date 7/17/2016 ; Service Code 2K8813 , Lot Number 160450175M , Exp. Date 5/6/2016 ; Service Code 2K8813 , Lot Number 160460213M , Exp. Date 5/7/2016 ; Service Code 2K8813 , Lot Number 160480240M , Exp. Date 5/9/2016 ; Service Code 2K8813 , Lot Number 160520185M , Exp. Date 5/13/2016 ; Service Code 2K8813 , Lot Number 160560083M , Exp. Date 5/16/2016 ; Service Code 2K8813 , Lot Number 160630156M , Exp. Date 5/24/2016 ; Service Code 2K8813 , Lot Number 160700166M , Exp. Date 5/31/2016 ; Service Code 2K8813 , Lot Number 160770183M , Exp. Date 6/7/2016 ; Service Code 2K8813 , Lot Number 160830180M , Exp. Date 6/13/2016 ; Service Code 2K8813 , Lot Number 160910180M , Exp. Date 6/21/2016 ; Service Code 2K8875 , Lot Number 160660143M , Exp. Date 5/27/2016 ; Service Code 2K8875 , Lot Number 160770127M , Exp. Date 6/7/2016 ; Service Code 2K8875 , Lot Number 160940123M , Exp. Date 6/24/2016 ; Service Code 2K8876 , Lot Number 160490225M , Exp. Date 5/10/2016 ; Service Code 2K8876 , Lot Number 160540244M , Exp. Date 5/15/2016 ; Service Code 2K8876 , Lot Number 160540245M , Exp. Date 5/15/2016 ; Service Code 2K8876 , Lot Number 160630129M , Exp. Date 5/24/2016 ; Service Code 2K8876 , Lot Number 160700161M , Exp. Date 5/31/2016 ; Service Code 2K8876 , Lot Number 160770137M , Exp. Date 6/7/2016 ; Service Code 2K8876 , Lot Number 160810190M , Exp. Date 6/11/2016 ; Service Code 2K8876 , Lot Number 160830187M , Exp. Date 6/13/2016 ; Service Code 2K8876 , Lot Number 160830188M , Exp. Date 6/13/2016 ; Service Code 2K8876 , Lot Number 160830189M , Exp. Date 6/13/2016 ; Service Code 2K8876 , Lot Number 160910229M , Exp. Date 6/21/2016 ; Service Code 2K8876 , Lot Number 161080079M , Exp. Date 7/7/2016 ; Service Code 2T6140 , Lot Number 160380106M , Exp. Date 5/7/2016 ; Service Code 2T6140 , Lot Number 160460193M , Exp. Date 5/16/2016 ; Service Code 2T6140 , Lot Number 160520182M , Exp. Date 5/22/2016 ; Service Code 2T6140 , Lot Number 160540193M , Exp. Date 5/23/2016 ; Service Code 2T6140 , Lot Number 160560094M , Exp. Date 5/25/2016 ; Service Code 2T6140 , Lot Number 160600050M , Exp. Date 5/29/2016 ; Service Code 2T6140 , Lot Number 160660153M , Exp. Date 6/5/2016 ; Service Code 2T6140 , Lot Number 160950214M , Exp. Date 7/4/2016 ; Service Code 2T6222 , Lot Number 160420160M , Exp. Date 5/11/2016 ; Service Code 2T8875 , Lot Number 160960145M , Exp. Date 5/6/2016 ; Service Code 2T8876 , Lot Number 160960131M , Exp. Date 5/6/2016 ; Service Code 4J8139 , Lot Number 160460122M , Exp. Date 5/10/2016 ; Service Code 4J8139 , Lot Number 160680045M , Exp. Date 5/31/2016 ; Service Code 4J8139 , Lot Number 160810171M , Exp. Date 6/14/2016 ; Service Code 4J8139 , Lot Number 160950057M , 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.
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