Recalls / Class II
Class IID-1377-2016
Product
1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths Medical Cassette, flow stop free-flow protection ((NDC 61553-878-52), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Affected lot / code info
- Service Code 2T8232 , Lot Number 160970019C , Exp. Date 5/7/2016 ; Service Code 2T8878 , Lot Number 160450193M , Exp. Date 5/6/2016 ; Service Code 2T8878 , Lot Number 160470227M , Exp. Date 5/8/2016 ; Service Code 2T8878 , Lot Number 160590187M , Exp. Date 5/19/2016 ; Service Code 2T8878 , Lot Number 160630026M , Exp. Date 5/23/2016 ; Service Code 2T8878 , Lot Number 160700162M , Exp. Date 5/31/2016 ; Service Code 2T8878 , Lot Number 160710004M , Exp. Date 5/31/2016 ; Service Code 2T8878 , Lot Number 160740228M , Exp. Date 6/4/2016 ; Service Code 2T8878 , Lot Number 160750111M , Exp. Date 6/4/2016 ; Service Code 2T8878 , Lot Number 160900226M , Exp. Date 6/20/2016 ; Service Code 2T8878 , Lot Number 161080176M , Exp. Date 7/8/2016 ;
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
- 384 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-1377-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.