Recalls / Class II
Class IID-1388-2016
Product
16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL in 3 mL BD Syringe, Service Code 2T6228, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-228-96
- Affected lot / code info
- Lot Number 160410126M , Exp. Date 5/10/2016 ; Lot Number 160450114M , Exp. Date 5/14/2016 ; Lot Number 160460158M , Exp. Date 5/15/2016 ; Lot Number 160670040M , Exp. Date 6/5/2016 ; Lot Number 160730148M , Exp. Date 6/12/2016 ; Lot Number 160840112M , 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
- 230 BD 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-1388-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.