Recalls / Class II
Class IID-1389-2016
Product
2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8103, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-103-48
- Affected lot / code info
- Lot Number 160390174M , Exp. Date 5/9/2016 ; Lot Number 160400196M , Exp. Date 5/10/2016 ; Lot Number 160470128M , Exp. Date 5/17/2016 ; Lot Number 160530287M , Exp. Date 5/23/2016 ; Lot Number 160540190M , Exp. Date 5/24/2016 ; Lot Number 160590168M , Exp. Date 5/29/2016 ; Lot Number 160610129M , Exp. Date 5/31/2016 ; Lot Number 160680254M , Exp. Date 6/7/2016 ; Lot Number 160700199M , Exp. Date 6/9/2016 ; Lot Number 160750132M , Exp. Date 6/14/2016 ; Lot Number 160770177M , Exp. Date 6/16/2016 ; Lot Number 160810292M , Exp. Date 6/20/2016 ; Lot Number 160820115M , Exp. Date 6/21/2016 ; Lot Number 160840157M , Exp. Date 6/23/2016 ; Lot Number 160880249M , Exp. Date 6/27/2016 ; Lot Number 160890261M , Exp. Date 6/28/2016 ; Lot Number 160940057M , Exp. Date 7/2/2016 ; Lot Number 160960151M , 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
- 425 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-1389-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.