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Recall Observatory FDA recall evidence

Drug product

20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8216, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-216-96

D-1411-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
212 Medical Cassettes
Official record key
drug-enforcement:D-1411-2016

Official wording

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

Code information: Lot Number 160600315M , Exp. Date 5/7/2016 ; Lot Number 160670256M , Exp. Date 5/14/2016 ; Lot Number 160730057M , Exp. Date 5/20/2016 ; Lot Number 160740144M , Exp. Date 5/20/2016 ; Lot Number 160800152M , Exp. Date 5/27/2016 ; Lot Number 160900142M , Exp. Date 6/5/2016 ; Lot Number 160910123M , Exp. Date 6/6/2016 ; Lot Number 160940037M , Exp. Date 6/9/2016 ; Lot Number 161080048M , Exp. Date 6/24/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter