Recalls / Class II
Class IID-1434-2016
Product
8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50
- Affected lot / code info
- Lot Number 160390094M , Exp. Date 5/9/2016 ; Lot Number 160450111M , Exp. Date 5/15/2016 ; Lot Number 160520101M , Exp. Date 5/22/2016 ; Lot Number 160550109M , Exp. Date 5/25/2016 ; Lot Number 160610124M , Exp. Date 5/31/2016 ; Lot Number 160620115M , Exp. Date 6/1/2016 ; Lot Number 160670036M , Exp. Date 6/5/2016 ; Lot Number 160680038M , Exp. Date 6/7/2016 ; Lot Number 160690110M , Exp. Date 6/7/2016 ; Lot Number 160740117M , Exp. Date 6/12/2016 ; Lot Number 160760109M , Exp. Date 6/15/2016 ; Lot Number 160820103M , Exp. Date 6/21/2016 ; Lot Number 160830107M , Exp. Date 6/22/2016 ; Lot Number 160900032M , Exp. Date 6/29/2016 ; Lot Number 160970021M , Exp. Date 7/6/2016 ;
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
- 650 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-1434-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.