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Recall Observatory FDA recall evidence

Drug product

0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

D-1372-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
866 bags
Official record key
drug-enforcement:D-1372-2016

Official wording

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

Code information: Service Code 2N1488 , Lot Number 160520176M , Exp. Date 5/22/2016 ; Service Code 2N1488 , Lot Number 160600059M , Exp. Date 5/30/2016 ; Service Code 2N1488 , Lot Number 160970115M , Exp. Date 7/5/2016 ; Service Code 2N1489 , Lot Number 160490027C , Exp. Date 5/19/2016 ; Service Code 2N1489 , Lot Number 160560032C , Exp. Date 5/26/2016 ; Service Code 2N1489 , Lot Number 160620024C , Exp. Date 6/1/2016 ; Service Code 2N1489 , Lot Number 160630029C , Exp. Date 6/2/2016 ; Service Code 2N1489 , Lot Number 160670059C , Exp. Date 6/6/2016 ; Service Code 2N1489 , Lot Number 160700047C , Exp. Date 6/9/2016 ; Service Code 2N1489 , Lot Number 160730025C , Exp. Date 6/12/2016 ; Service Code 2N1489 , Lot Number 160810057C , Exp. Date 6/20/2016 ; Service Code 2R3332-5 , Lot Number 160420156M , Exp. Date 5/11/2016 ; Service Code 2R3332-5 , Lot Number 160470152M , Exp. Date 5/16/2016 ; Service Code 2R3332-5 , Lot Number 160620035M , Exp. Date 5/31/2016 ; Service Code 2R3332-5 , Lot Number 160770159M , Exp. Date 6/16/2016 ; Service Code 2R3332-5 , Lot Number 160830044M , Exp. Date 6/21/2016 ; Service Code 2R3332-5 , Lot Number 160970032M , Exp. Date 7/5/2016 ; Service Code 3332NO , Lot Number 160380115M , Exp. Date 5/7/2016 ; Service Code 3332NO , Lot Number 160420112M , Exp. Date 5/11/2016 ; Service Code 3332NO , Lot Number 160540138M , Exp. Date 5/24/2016 ; Service Code 3332NO , Lot Number 160660215M , Exp. Date 6/5/2016 ; Service Code 3332NO , Lot Number 160690125M , Exp. Date 6/7/2016 ; Service Code 3332NO , Lot Number 160750228M , Exp. Date 6/14/2016 ; Service Code 3332NO , Lot Number 160900145M , Exp. Date 6/28/2016 ; Service Code 3332NO , Lot Number 160950153M , Exp. Date 7/4/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter