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Recall Observatory FDA recall evidence

Drug product

5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, Service Code 2T8200, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-200-52

D-1427-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
45 Medical Cassettes
Official record key
drug-enforcement:D-1427-2016

Official wording

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

Code information: Lot Number 160500008M , Exp. Date 5/10/2016 ; Lot Number 160940038C , Exp. Date 6/24/2016 ; Lot Number 160970126M , Exp. Date 6/27/2016 ; Lot Number 161080140M , Exp. Date 7/8/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter