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Recall Observatory FDA recall evidence

Drug product

16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL in 3 mL BD Syringe, Service Code 2T6228, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-228-96

D-1388-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
230 BD syringes
Official record key
drug-enforcement:D-1388-2016

Official wording

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Code information: Lot Number 160410126M , Exp. Date 5/10/2016 ; Lot Number 160450114M , Exp. Date 5/14/2016 ; Lot Number 160460158M , Exp. Date 5/15/2016 ; Lot Number 160670040M , Exp. Date 6/5/2016 ; Lot Number 160730148M , Exp. Date 6/12/2016 ; Lot Number 160840112M , Exp. Date 6/22/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter