Recalls / Class II
Class IID-1375-2016
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
- Affected lot / code info
- 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 ;
Why it was recalled
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 1,527 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-05-05
- FDA classified
- 2016-07-16
- Posted by FDA
- 2016-07-27
- Terminated
- 2018-03-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1375-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.