CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl recalled
Pharmedium Services is recalling 2 mcg/mL Fentanyl Citrate and 0.083% 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-1394-2016
- 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 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), 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 2K8176 , Lot Number 160460099M , Exp. Date 5/10/2016 ; Service Code 2K8176 , Lot Number 160480269M , Exp. Date 5/12/2016 ; Service Code 2K8176 , Lot Number 160560160M , Exp. Date 5/20/2016 ; Service Code 2K8176 , Lot Number 160630171M , Exp. Date 5/27/2016 ; Service Code 2K8176 , Lot Number 160690141M , Exp. Date 6/2/2016 ; Service Code 2K8176 , Lot Number 160740128M , Exp. Date 6/7/2016 ; Service Code 2K8176 , Lot Number 160750247M , Exp. Date 6/8/2016 ; Service Code 2K8176 , Lot Number 160810137M , Exp. Date 6/14/2016 ; Service Code 2K8176 , Lot Number 160870187M , Exp. Date 6/20/2016 ; Service Code 2K8176 , Lot Number 160940253M , Exp. Date 6/27/2016 ; Service Code 2K8176 , Lot Number 161080131M , Exp. Date 7/11/2016 ; Service Code 2K8871 , Lot Number 160480223M , Exp. Date 5/8/2016 ; Service Code 2K8871 , Lot Number 160670054C , Exp. Date 5/28/2016 ; Service Code 2K8871 , Lot Number 160870033C , Exp. Date 6/17/2016 ; Service Code 2K8967 , Lot Number 16092001C , Exp. Date 6/21/2016 ; Service Code 2T8871 , Lot Number 160970026M , Exp. Date 5/7/2016 ;
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
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|---|---|---|---|---|---|
| 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 |