Recalls / Class II
Class IID-1411-2016
Product
20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8216, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-216-96
- Affected lot / code info
- Lot Number 160600315M , Exp. Date 5/7/2016 ; Lot Number 160670256M , Exp. Date 5/14/2016 ; Lot Number 160730057M , Exp. Date 5/20/2016 ; Lot Number 160740144M , Exp. Date 5/20/2016 ; Lot Number 160800152M , Exp. Date 5/27/2016 ; Lot Number 160900142M , Exp. Date 6/5/2016 ; Lot Number 160910123M , Exp. Date 6/6/2016 ; Lot Number 160940037M , Exp. Date 6/9/2016 ; Lot Number 161080048M , Exp. Date 6/24/2016 ;
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
- 212 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-1411-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.