CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recalled
Pharmedium Services is recalling 5 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-1425-206
- 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 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20
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 2H8138 , Lot Number 160410192M , Exp. Date 5/11/2016 ; Service Code 2H8138 , Lot Number 160600314M , Exp. Date 5/30/2016 ; Service Code 2H8138 , Lot Number 160690002M , Exp. Date 6/7/2016 ; Service Code 2H8138 , Lot Number 160690191M , Exp. Date 6/8/2016 ; Service Code 2H8138 , Lot Number 160740233M , Exp. Date 6/13/2016 ; Service Code 2H8138 , Lot Number 160760163M , Exp. Date 6/14/2016 ; Service Code 2H8138 , Lot Number 160830226M , Exp. Date 6/22/2016 ; Service Code 2H8138 , Lot Number 160890256M , Exp. Date 6/28/2016 ; Service Code 2H8138 , Lot Number 160940138M , Exp. Date 7/3/2016 ; Service Code 2H8138 , Lot Number 160960197M , Exp. Date 7/5/2016 ; Service Code 2H8138 , Lot Number 161080219M , Exp. Date 7/17/2016 ; Service Code 2K8138 , Lot Number 160450061M , Exp. Date 5/9/2016 ; Service Code 2K8138 , Lot Number 160470232M , Exp. Date 5/11/2016 ; Service Code 2K8138 , Lot Number 160480268M , Exp. Date 5/12/2016 ; Service Code 2K8138 , Lot Number 160590083M , Exp. Date 5/23/2016 ; Service Code 2K8138 , Lot Number 160630170M , Exp. Date 5/27/2016 ; Service Code 2K8138 , Lot Number 160690170M , Exp. Date 6/2/2016 ; Service Code 2K8138 , Lot Number 160700150M , Exp. Date 6/3/2016 ; Service Code 2K8138 , Lot Number 160770283M , Exp. Date 6/10/2016 ; Service Code 2K8138 , Lot Number 160840146M , Exp. Date 6/17/2016 ; Service Code 2K8138 , Lot Number 160910269M , Exp. Date 6/24/2016 ; Service Code 2K8138 , Lot Number 161080325M , Exp. Date 7/11/2016 ; Service Code 2K8807 , Lot Number 160490044C , Exp. Date 5/10/2016 ; Service Code 2K8807 , Lot Number 160630012C , Exp. Date 5/24/2016 ; Service Code 2K8807 , Lot Number 160700033C , Exp. Date 5/31/2016 ; Service Code 2K8807 , Lot Number 160970033C , Exp. Date 6/27/2016 ; Service Code 2K8872 , Lot Number 160600059C , Exp. Date 5/21/2016 ; Service Code 2K8872 , Lot Number 160630026C , Exp. Date 5/24/2016 ; Service Code 2K8872 , Lot Number 160660158M , Exp. Date 5/27/2016 ; Service Code 2K8872 , Lot Number 160740036M , Exp. Date 6/3/2016 ; Service Code 2K8872 , Lot Number 160880252M , Exp. Date 6/18/2016 ; Service Code 2K8872 , Lot Number 160940031C , Exp. Date 6/24/2016 ; Service Code 2K9138 , Lot Number 160420038C , Exp. Date 5/12/2016 ; Service Code 2K9138 , Lot Number 160460045C , Exp. Date 5/16/2016 ; Service Code 2K9138 , Lot Number 160520033C , Exp. Date 5/22/2016 ; Service Code 2K9138 , Lot Number 160530050C , Exp. Date 5/23/2016 ; Service Code 2K9138 , Lot Number 160590029C , Exp. Date 5/29/2016 ; Service Code 2K9138 , Lot Number 160600062C , Exp. Date 5/30/2016 ; Service Code 2K9138 , Lot Number 160630033C , Exp. Date 6/2/2016 ; Service Code 2K9138 , Lot Number 160670077C , Exp. Date 6/6/2016 ; Service Code 2K9138 , Lot Number 160730033C , Exp. Date 6/12/2016 ; Service Code 2K9138 , Lot Number 160770056C , Exp. Date 6/16/2016 ; Service Code 2K9138 , Lot Number 160880076C , Exp. Date 6/27/2016 ; Service Code 2K9138 , Lot Number 160910024C , Exp. Date 6/30/2016 ; Service Code 2K9138 , Lot Number 160950084C , Exp. Date 7/4/2016 ; Service Code 2K9138 , Lot Number 160960054C , Exp. Date 7/5/2016 ; Service Code 2T6257 , Lot Number 160450201M , Exp. Date 5/15/2016 ; Service Code 2T6257 , Lot Number 160620194M , Exp. Date 6/1/2016 ; Service Code 2T6257 , Lot Number 160810203M , Exp. Date 6/20/2016 ; Service Code 2T6257 , Lot Number 160820230M , Exp. Date 6/21/2016 ; Service Code 2T6257 , Lot Number 160870153M , Exp. Date 6/26/2016 ; Service Code 2T6257 , Lot Number 160880278M , Exp. Date 6/27/2016 ; Service Code 2T6257 , Lot Number 160950233M , Exp. Date 7/4/2016 ; Service Code 2T8141 , Lot Number 160450016C , Exp. Date 5/6/2016 ; Service Code 2T8141 , Lot Number 160520016C , Exp. Date 5/13/2016 ; Service Code 2T8141 , Lot Number 160530019C , Exp. Date 5/14/2016 ; Service Code 2T8141 , Lot Number 160590009C , Exp. Date 5/20/2016 ; Service Code 2T8141 , Lot Number 160670022C , Exp. Date 5/28/2016 ; Service Code 2T8141 , Lot Number 160730011C , Exp. Date 6/3/2016 ; Service Code 2T8141 , Lot Number 160740029C , Exp. Date 6/3/2016 ; Service Code 2T8141 , Lot Number 160800022C , Exp. Date 6/10/2016 ; Service Code 2T8141 , Lot Number 160870008C , Exp. Date 6/17/2016 ;
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 | nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
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