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Recall Observatory FDA recall evidence

Drug product

2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48

D-1404-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
85 Medical Cassettes
Official record key
drug-enforcement:D-1404-2016

Official wording

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

Code information: Service Code 2K8892 , Lot Number 160560168M , Exp. Date 5/17/2016 ; Service Code 2K8892 , Lot Number 160810001M , Exp. Date 6/10/2016 ; Service Code 2K8219 , Lot Number 160530297M , Exp. Date 5/23/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter