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Recall Observatory FDA recall evidence

Drug product

10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

D-1381-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
600 Monoject Syringes
Official record key
drug-enforcement:D-1381-2016

Official wording

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

Code information: Service Code 2T6014 , Lot Number 160390220M , Exp. Date 5/9/2016 ; Service Code 2T6014 , Lot Number 160700029M , Exp. Date 6/8/2016 ; Service Code 2T6636 , Lot Number 160380145M , Exp. Date 5/7/2016 ; Service Code 2T6636 , Lot Number 160390003M , Exp. Date 5/8/2016 ; Service Code 2T6636 , Lot Number 160460177M , Exp. Date 5/15/2016 ; Service Code 2T6636 , Lot Number 160490165M , Exp. Date 5/18/2016 ; Service Code 2T6636 , Lot Number 160550201M , Exp. Date 5/24/2016 ; Service Code 2T6636 , Lot Number 160670237M , Exp. Date 6/6/2016 ; Service Code 2T6636 , Lot Number 160680008M , Exp. Date 6/6/2016 ; Service Code 2T6636 , Lot Number 160700023M , Exp. Date 6/8/2016 ; Service Code 2T6636 , Lot Number 160710003M , Exp. Date 6/9/2016 ; Service Code 2T6636 , Lot Number 160740258M , Exp. Date 6/13/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter