CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recalled
Pharmedium Services is recalling 2.5 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-1405-2016
- 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
2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), 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 2H8255 , Lot Number 160550161M , Exp. Date 5/11/2016 ; Service Code 2H8255 , Lot Number 160620170M , Exp. Date 5/18/2016 ; Service Code 2H8255 , Lot Number 160760132M , Exp. Date 6/1/2016 ; Service Code 2H8255 , Lot Number 160830148M , Exp. Date 6/8/2016 ; Service Code 2H8255 , Lot Number 160900158M , Exp. Date 6/15/2016 ; Service Code 2H8255 , Lot Number 160970139M , Exp. Date 6/22/2016 ; Service Code 2K8255 , Lot Number 160490046C , Exp. Date 5/13/2016 ; Service Code 2K8255 , Lot Number 160620032C , Exp. Date 5/26/2016 ; Service Code 2K8255 , Lot Number 160770046C , Exp. Date 6/10/2016 ; Service Code 2K8464 , Lot Number 160420154M , Exp. Date 5/6/2016 ; Service Code 2K8464 , Lot Number 160530249M , Exp. Date 5/17/2016 ; Service Code 2K8464 , Lot Number 160540207M , Exp. Date 5/18/2016 ; Service Code 2K8464 , Lot Number 160660045M , Exp. Date 5/29/2016 ; Service Code 2K8464 , Lot Number 160730092M , Exp. Date 6/6/2016 ; Service Code 2K8464 , Lot Number 160840137M , Exp. Date 6/17/2016 ; Service Code 2K8464 , Lot Number 160910145M , Exp. Date 6/24/2016 ; Service Code 2T8255 , Lot Number 160480271M , Exp. Date 5/9/2016 ; Service Code 2T8255 , Lot Number 160530302M , Exp. Date 5/14/2016 ; Service Code 2T8255 , Lot Number 160600047C , Exp. Date 5/21/2016 ; Service Code 2T8255 , Lot Number 160610032C , Exp. Date 5/22/2016 ; Service Code 2T8255 , Lot Number 160700030C , Exp. Date 5/30/2016 ; Service Code 2T8255 , Lot Number 160700031C , Exp. Date 5/31/2016 ; Service Code 2T8255 , Lot Number 160740060C , Exp. Date 6/4/2016 ; Service Code 2T8255 , Lot Number 160770034C , Exp. Date 6/7/2016 ; Service Code 2T8255 , Lot Number 160830059C , Exp. Date 6/13/2016 ; Service Code 2T8255 , Lot Number 160880040C , Exp. Date 6/18/2016 ; Service Code 2T8255 , Lot Number 160880041C , Exp. Date 6/18/2016 ; Service Code 2T8255 , Lot Number 160940029C , Exp. Date 6/24/2016 ; Service Code 2T8255 , Lot Number 160950051C , Exp. Date 6/25/2016 ;
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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|---|---|---|---|---|---|
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| 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 |