FDAFDA · Food and drugs·Recall number D-1427-2016
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
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
- 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 ;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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