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Recall Observatory FDA recall evidence

Drug product

10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-17

D-1383-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
55 bags
Official record key
drug-enforcement:D-1383-2016

Official wording

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

Code information: Lot Number 160470116M , Exp. Date 5/17/2016 ; Lot Number 160490123M , Exp. Date 5/19/2016 ; Lot Number 160800048M , Exp. Date 6/18/2016 ; Lot Number 160890060M , Exp. Date 6/27/2016 ; Lot Number 160940050M , Exp. Date 7/2/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter