Recalls / Class II
Class IID-1393-2016
Product
2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8296 (NDC 61553-296-52), 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8296 (NDC 61553-296-22), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,
- Affected lot / code info
- Service Code 2H8296 , Lot Number 160420192M , Exp. Date 5/8/2016 ; Service Code 2H8296 , Lot Number 160450199M , Exp. Date 5/11/2016 ; Service Code 2H8296 , Lot Number 160490146M , Exp. Date 5/15/2016 ; Service Code 2H8296 , Lot Number 160590180M , Exp. Date 5/25/2016 ; Service Code 2H8296 , Lot Number 160660231M , Exp. Date 6/1/2016 ; Service Code 2H8296 , Lot Number 160700136M , Exp. Date 6/5/2016 ; Service Code 2H8296 , Lot Number 160770233M , Exp. Date 6/12/2016 ; Service Code 2H8296 , Lot Number 160820140M , Exp. Date 6/17/2016 ; Service Code 2H8296 , Lot Number 160880282M , Exp. Date 6/23/2016 ; Service Code 2H8296 , Lot Number 160910131M , Exp. Date 6/26/2016 ; Service Code 2H8296 , Lot Number 160970117M , Exp. Date 7/1/2016 ; Service Code 2H8296 , Lot Number 161080157M , Exp. Date 7/13/2016 ; Service Code 2K8296 , Lot Number 160420191M , Exp. Date 5/12/2016 ; Service Code 2K8296 , Lot Number 160480230M , Exp. Date 5/18/2016 ; Service Code 2K8296 , Lot Number 160540227M , Exp. Date 5/24/2016 ; Service Code 2K8296 , Lot Number 160610205M , Exp. Date 5/31/2016 ; Service Code 2K8296 , Lot Number 160670249M , Exp. Date 6/6/2016 ; Service Code 2K8296 , Lot Number 160830181M , Exp. Date 6/22/2016 ; Service Code 2K8296 , Lot Number 160840213M , Exp. Date 6/23/2016 ; Service Code 2T6296 , Lot Number 160450196M , Exp. Date 5/15/2016 ; Service Code 2T6296 , Lot Number 160530159M , Exp. Date 5/23/2016 ; Service Code 2T6296 , Lot Number 160690195M , Exp. Date 6/8/2016 ; Service Code 2T6296 , Lot Number 160750219M , Exp. Date 6/14/2016 ; Service Code 2T6296 , Lot Number 160810166M , Exp. Date 6/20/2016 ; Service Code 2T6296 , Lot Number 160880176M , Exp. Date 6/26/2016 ; Service Code 2T6296 , Lot Number 160940048M , Exp. Date 7/2/2016 ; Service Code 2T6296 , Lot Number 160970123M , Exp. Date 7/5/2016 ;
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
- 1,476 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-1393-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.