Recalls / Class II
Class IID-1378-2016
Product
10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-143-50
- Affected lot / code info
- Service Code 2H8143 , Lot Number 160830115M , Exp. Date 6/22/2016 ; Service Code 2H8143 , Lot Number 160910155M , Exp. Date 6/30/2016 ; Service Code 2K8448 , Lot Number 160480205M , Exp. Date 5/12/2016 ; Service Code 2K8448 , Lot Number 160610064M , Exp. Date 5/24/2016 ; Service Code 2K8448 , Lot Number 160760042M , Exp. Date 6/9/2016 ; Service Code 2K8448 , Lot Number 160890047M , Exp. Date 6/22/2016 ;
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
- 65 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-1378-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.