Recalls / Class II
Class IID-1394-2016
Product
2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Affected lot / code info
- Service Code 2K8176 , Lot Number 160460099M , Exp. Date 5/10/2016 ; Service Code 2K8176 , Lot Number 160480269M , Exp. Date 5/12/2016 ; Service Code 2K8176 , Lot Number 160560160M , Exp. Date 5/20/2016 ; Service Code 2K8176 , Lot Number 160630171M , Exp. Date 5/27/2016 ; Service Code 2K8176 , Lot Number 160690141M , Exp. Date 6/2/2016 ; Service Code 2K8176 , Lot Number 160740128M , Exp. Date 6/7/2016 ; Service Code 2K8176 , Lot Number 160750247M , Exp. Date 6/8/2016 ; Service Code 2K8176 , Lot Number 160810137M , Exp. Date 6/14/2016 ; Service Code 2K8176 , Lot Number 160870187M , Exp. Date 6/20/2016 ; Service Code 2K8176 , Lot Number 160940253M , Exp. Date 6/27/2016 ; Service Code 2K8176 , Lot Number 161080131M , Exp. Date 7/11/2016 ; Service Code 2K8871 , Lot Number 160480223M , Exp. Date 5/8/2016 ; Service Code 2K8871 , Lot Number 160670054C , Exp. Date 5/28/2016 ; Service Code 2K8871 , Lot Number 160870033C , Exp. Date 6/17/2016 ; Service Code 2K8967 , Lot Number 16092001C , Exp. Date 6/21/2016 ; Service Code 2T8871 , Lot Number 160970026M , Exp. Date 5/7/2016 ;
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
- 1,280 Medical Cassettes
- 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-1394-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.