Drug product
1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95
D-1375-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,527 bags
- Official record key
drug-enforcement:D-1375-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Service Code 2K9998 , Lot Number 160460135M , Exp. Date 5/10/2016 ; Service Code 2K9998 , Lot Number 160530146M , Exp. Date 5/17/2016 ; Service Code 2K9998 , Lot Number 160590137M , Exp. Date 5/23/2016 ; Service Code 2K9998 , Lot Number 160660221M , Exp. Date 5/30/2016 ; Service Code 2K9998 , Lot Number 160730163M , Exp. Date 6/6/2016 ; Service Code 2K9998 , Lot Number 160870147M , Exp. Date 6/20/2016 ; Service Code 2K9998 , Lot Number 160880265M , Exp. Date 6/21/2016 ; Service Code 2K9998 , Lot Number 160940206M , Exp. Date 6/27/2016 ; Service Code 2K9998 , Lot Number 161080210M , Exp. Date 7/11/2016 ; Service Code 2T8998 , Lot Number 160460267M , Exp. Date 5/7/2016 ; Service Code 2T8998 , Lot Number 160470042M , Exp. Date 5/8/2016 ; Service Code 2T8998 , Lot Number 160530034M , Exp. Date 5/14/2016 ; Service Code 2T8998 , Lot Number 160610043M , Exp. Date 5/22/2016 ; Service Code 2T8998 , Lot Number 160640008M , Exp. Date 5/24/2016 ; Service Code 2T8998 , Lot Number 160690011C , Exp. Date 5/30/2016 ; Service Code 2T8998 , Lot Number 160690012C , Exp. Date 5/30/2016 ; Service Code 2T8998 , Lot Number 160740064C , Exp. Date 6/4/2016 ; Service Code 2T8998 , Lot Number 160810066C , Exp. Date 6/11/2016 ; Service Code 2T8998 , Lot Number 160840030C , Exp. Date 6/14/2016 ; Service Code 2T8998 , Lot Number 160880042C , Exp. Date 6/18/2016 ; Service Code 2T8998 , Lot Number 160880043C , Exp. Date 6/18/2016 ; Service Code 2T8998 , Lot Number 160910014C , Exp. Date 6/21/2016 ; Service Code 2T8998 , Lot Number 160910015C , Exp. Date 6/21/2016 ; Service Code 2T8998 , Lot Number 160950071C , Exp. Date 6/25/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter