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Recall Observatory FDA recall evidence

Drug product

2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9276, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-276-98

D-1400-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
480 bags
Official record key
drug-enforcement:D-1400-2016

Official wording

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

Code information: Lot Number 160480033C , Exp. Date 5/12/2016 ; Lot Number 160520027C , Exp. Date 5/16/2016 ; Lot Number 160610040C , Exp. Date 5/25/2016 ; Lot Number 160750051C , Exp. Date 6/8/2016 ; Lot Number 160800038C , Exp. Date 6/13/2016 ; Lot Number 160880045C , Exp. Date 6/21/2016 ; Lot Number 160940037C , Exp. Date 6/27/2016 ; Lot Number 160960035C , Exp. Date 6/29/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter