Recalls / Class II
Class IID-1381-2016
Product
10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Affected lot / code info
- Service Code 2T6014 , Lot Number 160390220M , Exp. Date 5/9/2016 ; Service Code 2T6014 , Lot Number 160700029M , Exp. Date 6/8/2016 ; Service Code 2T6636 , Lot Number 160380145M , Exp. Date 5/7/2016 ; Service Code 2T6636 , Lot Number 160390003M , Exp. Date 5/8/2016 ; Service Code 2T6636 , Lot Number 160460177M , Exp. Date 5/15/2016 ; Service Code 2T6636 , Lot Number 160490165M , Exp. Date 5/18/2016 ; Service Code 2T6636 , Lot Number 160550201M , Exp. Date 5/24/2016 ; Service Code 2T6636 , Lot Number 160670237M , Exp. Date 6/6/2016 ; Service Code 2T6636 , Lot Number 160680008M , Exp. Date 6/6/2016 ; Service Code 2T6636 , Lot Number 160700023M , Exp. Date 6/8/2016 ; Service Code 2T6636 , Lot Number 160710003M , Exp. Date 6/9/2016 ; Service Code 2T6636 , Lot Number 160740258M , Exp. Date 6/13/2016 ;
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
- 600 Monoject Syringes
- 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-1381-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.