FDAFDA · Food and drugs·Recall number D-1377-2016
1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths Medical Cassette, flow stop free-flow protection ((NDC 61553-878-52), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Published July 27, 2016 · Recall initiated: May 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Pharmedium Services, LLC
- Distributor
- Nationwide
- Lot
- Service Code 2T8232 , Lot Number 160970019C , Exp. Date 5/7/2016 ; Service Code 2T8878 , Lot Number 160450193M , Exp. Date 5/6/2016 ; Service Code 2T8878 , Lot Number 160470227M , Exp. Date 5/8/2016 ; Service Code 2T8878 , Lot Number 160590187M , Exp. Date 5/19/2016 ; Service Code 2T8878 , Lot Number 160630026M , Exp. Date 5/23/2016 ; Service Code 2T8878 , Lot Number 160700162M , Exp. Date 5/31/2016 ; Service Code 2T8878 , Lot Number 160710004M , Exp. Date 5/31/2016 ; Service Code 2T8878 , Lot Number 160740228M , Exp. Date 6/4/2016 ; Service Code 2T8878 , Lot Number 160750111M , Exp. Date 6/4/2016 ; Service Code 2T8878 , Lot Number 160900226M , Exp. Date 6/20/2016 ; Service Code 2T8878 , Lot Number 161080176M , Exp. Date 7/8/2016 ;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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