Recalls / Class II
Class IID-1401-2016
Product
2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02
- Affected lot / code info
- Lot Number 160420104M , Exp. Date 5/6/2016 ; Lot Number 160450187M , Exp. Date 5/9/2016 ; Lot Number 160530126M , Exp. Date 5/17/2016 ; Lot Number 160680200M , Exp. Date 6/1/2016 ; Lot Number 160730047M , Exp. Date 6/5/2016 ; Lot Number 160750130M , Exp. Date 6/8/2016 ; Lot Number 160830227M , Exp. Date 6/16/2016 ; Lot Number 160870077M , Exp. Date 6/19/2016 ;
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
- 90 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-1401-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.