CLASS IIDrug recall · Reported 27 Jul 2016 · FDA Enforcement Report
6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled
Pharmedium Services is recalling 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9%, 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
Lot, batch or date codesLot Number 160480035C , Exp. Date 5/18/2016 ; Lot Number 160560026C , Exp. Date 5/26/2016 ; Lot Number 160620029C , Exp. Date 6/1/2016 ; Lot Number 160630001C , Exp. Date 6/1/2016 ; Lot Number 160810283M , Exp. Date 6/20/2016 ; Lot Number 160880013C , Exp. Date 6/27/2016 ; Lot Number 160890043C , Exp. Date 6/28/2016 ;
Quantity recalled180 syringes
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.
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
6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-993-86
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Which lots are affected?
Lot Number 160480035C , Exp. Date 5/18/2016 ; Lot Number 160560026C , Exp. Date 5/26/2016 ; Lot Number 160620029C , Exp. Date 6/1/2016 ; Lot Number 160630001C , Exp. Date 6/1/2016 ; Lot Number 160810283M , Exp. Date 6/20/2016 ; Lot Number 160880013C , Exp. Date 6/27/2016 ; Lot Number 160890043C , Exp. Date 6/28/2016 ;
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.