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Recall Observatory FDA recall evidence

Drug product

20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12

D-1409-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
435 Monoject Syringes
Official record key
drug-enforcement:D-1409-2016

Official wording

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

Code information: Service Code 2K8157 , Lot Number 160420116M , Exp. Date 5/12/2016 ; Service Code 2K8157 , Lot Number 160540135M , Exp. Date 5/24/2016 ; Service Code 2K8157 , Lot Number 160630121M , Exp. Date 6/2/2016 ; Service Code 2K8157 , Lot Number 160730218M , Exp. Date 6/12/2016 ; Service Code 2K8157 , Lot Number 160760126M , Exp. Date 6/14/2016 ; Service Code 2K8157 , Lot Number 160770152M , Exp. Date 6/16/2016 ; Service Code 2K8157 , Lot Number 160810169M , Exp. Date 6/20/2016 ; Service Code 2K8157 , Lot Number 160840206M , Exp. Date 6/23/2016 ; Service Code 2K8157 , Lot Number 160940210M , Exp. Date 7/3/2016 ; Service Code 2T6620 , Lot Number 160900133M , Exp. Date 5/6/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter