Recalls / Class II
Class IID-1380-2016
Product
10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02
- Affected lot / code info
- Lot Number 160460189M , Exp. Date 5/10/2016 ; Lot Number 160480179M , Exp. Date 5/12/2016 ; Lot Number 160520105M , Exp. Date 5/15/2016 ; Lot Number 160530291M , Exp. Date 5/17/2016 ; Lot Number 160540130M , Exp. Date 5/17/2016 ; Lot Number 160550186M , Exp. Date 5/19/2016 ; Lot Number 160560087M , Exp. Date 5/19/2016 ; Lot Number 160590074M , Exp. Date 5/23/2016 ; Lot Number 160620037M , Exp. Date 5/25/2016 ; Lot Number 160630028M , Exp. Date 5/26/2016 ; Lot Number 160660039M , Exp. Date 5/29/2016 ; Lot Number 160730059M , Exp. Date 6/6/2016 ; Lot Number 160740234M , Exp. Date 6/7/2016 ; Lot Number 160800073M , Exp. Date 6/12/2016 ; Lot Number 160820049M , Exp. Date 6/14/2016 ; Lot Number 160890045M , Exp. Date 6/21/2016 ; Lot Number 160970197M , Exp. Date 6/30/2016 ;
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
- N/A
- 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-1380-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.