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Recall Observatory FDA recall evidence

Drug product

3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8284 (NDC 61553-284-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

D-1415-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
1,470 bags
Official record key
drug-enforcement:D-1415-2016

Official wording

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

Code information: Service Code 2H8239 , Lot Number 160400232M , Exp. Date 5/10/2016 ; Service Code 2H8239 , Lot Number 160630193M , Exp. Date 6/2/2016 ; Service Code 2K8239 , Lot Number 160520143M , Exp. Date 5/16/2016 ; Service Code 2K8239 , Lot Number 160530306M , Exp. Date 5/17/2016 ; Service Code 2K8239 , Lot Number 160610250M , Exp. Date 5/25/2016 ; Service Code 2K8239 , Lot Number 160630167M , Exp. Date 5/27/2016 ; Service Code 2K8239 , Lot Number 160680214M , Exp. Date 6/1/2016 ; Service Code 2K8239 , Lot Number 160750241M , Exp. Date 6/8/2016 ; Service Code 2K8239 , Lot Number 160820181M , Exp. Date 6/15/2016 ; Service Code 2K8239 , Lot Number 160840225M , Exp. Date 6/17/2016 ; Service Code 2K8239 , Lot Number 160900186M , Exp. Date 6/23/2016 ; Service Code 2K8239 , Lot Number 160940234M , Exp. Date 6/27/2016 ; Service Code 2K8239 , Lot Number 161080183M , Exp. Date 7/11/2016 ; Service Code 2K8284 , Lot Number 160470223M , Exp. Date 5/17/2016 ; Service Code 2K8284 , Lot Number 160520118M , Exp. Date 5/22/2016 ; Service Code 2K8284 , Lot Number 160610207M , Exp. Date 5/31/2016 ; Service Code 2K8284 , Lot Number 160620153M , Exp. Date 6/1/2016 ; Service Code 2K8284 , Lot Number 160750236M , Exp. Date 6/14/2016 ; Service Code 2K8284 , Lot Number 160770226M , Exp. Date 6/16/2016 ; Service Code 2K8284 , Lot Number 160840209M , Exp. Date 6/23/2016 ; Service Code 2K8284 , Lot Number 160910218M , Exp. Date 6/30/2016 ; Service Code 2K8284 , Lot Number 160960157M , Exp. Date 7/5/2016 ; Service Code 2K8284 , Lot Number 161080227M , Exp. Date 7/17/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter