Recalls / Class II

Class IID-1416-2016

Product

3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8837 (NDC 61553-837-48), Service Code 2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service Code 2K8976 (NDC 61553-976-48), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Affected lot / code info: Service Code 3V8708 , Lot Number 160410168M , Exp. Date 5/11/2016 ; Service Code 3V8708 , Lot Number 160600286M , Exp. Date 5/30/2016 ; Service Code 3V8708 , Lot Number 160810284M , Exp. Date 6/20/2016 ; Service Code 3V8708 , Lot Number 160820091M , Exp. Date 6/20/2016 ; Service Code 2H8285 , Lot Number 160470170M , Exp. Date 5/13/2016 ; Service Code 2H8285 , Lot Number 160530182M , Exp. Date 5/19/2016 ; Service Code 2H8285 , Lot Number 160600296M , Exp. Date 5/26/2016 ; Service Code 2H8285 , Lot Number 160670185M , Exp. Date 6/2/2016 ; Service Code 2H8285 , Lot Number 160740253M , Exp. Date 6/9/2016 ; Service Code 2H8285 , Lot Number 160820206M , Exp. Date 6/17/2016 ; Service Code 2H8285 , Lot Number 160880254M , Exp. Date 6/23/2016 ; Service Code 2H8285 , Lot Number 160910152M , Exp. Date 6/26/2016 ; Service Code 2K8237 , Lot Number 160400261M , Exp. Date 5/10/2016 ; Service Code 2K8237 , Lot Number 160450263M , Exp. Date 5/15/2016 ; Service Code 2K8237 , Lot Number 160540239M , Exp. Date 5/24/2016 ; Service Code 2K8237 , Lot Number 160620203M , Exp. Date 6/1/2016 ; Service Code 2K8237 , Lot Number 160700152M , Exp. Date 6/9/2016 ; Service Code 2K8237 , Lot Number 160730269M , Exp. Date 6/12/2016 ; Service Code 2K8237 , Lot Number 160760207M , Exp. Date 6/15/2016 ; Service Code 2K8237 , Lot Number 160810315M , Exp. Date 6/20/2016 ; Service Code 2K8237 , Lot Number 160870248M , Exp. Date 6/26/2016 ; Service Code 2K8237 , Lot Number 160940250M , Exp. Date 7/3/2016 ; Service Code 2K8237 , Lot Number 160970220M , Exp. Date 7/6/2016 ; Service Code 2K8643 , Lot Number 160420245M , Exp. Date 5/12/2016 ; Service Code 2K8643 , Lot Number 160470238M , Exp. Date 5/17/2016 ; Service Code 2K8643 , Lot Number 160480261M , Exp. Date 5/18/2016 ; Service Code 2K8643 , Lot Number 160600351M , Exp. Date 5/30/2016 ; Service Code 2K8643 , Lot Number 160700177M , Exp. Date 6/9/2016 ; Service Code 2K8643 , Lot Number 160770260M , Exp. Date 6/16/2016 ; Service Code 2K8643 , Lot Number 160870191M , Exp. Date 6/26/2016 ; Service Code 2K8643 , Lot Number 160910247M , Exp. Date 6/30/2016 ; Service Code 2K8643 , Lot Number 161080279M , Exp. Date 7/17/2016 ; Service Code 2K8837 , Lot Number 160460262M , Exp. Date 5/7/2016 ; Service Code 2K8837 , Lot Number 160530235M , Exp. Date 5/14/2016 ; Service Code 2K8837 , Lot Number 160600335M , Exp. Date 5/21/2016 ; Service Code 2K8837 , Lot Number 160630109M , Exp. Date 5/24/2016 ; Service Code 2K8837 , Lot Number 160740138M , Exp. Date 6/4/2016 ; Service Code 2K8837 , Lot Number 160770249M , Exp. Date 6/7/2016 ; Service Code 2K8837 , Lot Number 160870243M , Exp. Date 6/17/2016 ; Service Code 2K8837 , Lot Number 160880159M , Exp. Date 6/18/2016 ; Service Code 2K8837 , Lot Number 160900184M , Exp. Date 6/20/2016 ; Service Code 2K8837 , Lot Number 160960129M , Exp. Date 6/26/2016 ; Service Code 2K8906 , Lot Number 160480019M , Exp. Date 5/9/2016 ; Service Code 2K8906 , Lot Number 160540174M , Exp. Date 5/15/2016 ; Service Code 2K8906 , Lot Number 160610163M , Exp. Date 5/22/2016 ; Service Code 2K8906 , Lot Number 160700148M , Exp. Date 5/31/2016 ; Service Code 2K8906 , Lot Number 160750221M , Exp. Date 6/5/2016 ; Service Code 2K8906 , Lot Number 160770136M , Exp. Date 6/7/2016 ; Service Code 2K8906 , Lot Number 160820127M , Exp. Date 6/12/2016 ; Service Code 2K8906 , Lot Number 160890210M , Exp. Date 6/19/2016 ; Service Code 2K8906 , Lot Number 160960171M , Exp. Date 6/26/2016 ; Service Code 2K8963 , Lot Number 160550244M , Exp. Date 5/16/2016 ; Service Code 2K8963 , Lot Number 160560180M , Exp. Date 5/17/2016 ; Service Code 2K8963 , Lot Number 160670202M , Exp. Date 5/28/2016 ; Service Code 2K8963 , Lot Number 160750055C , Exp. Date 6/5/2016 ; Service Code 2K8963 , Lot Number 160760031C , Exp. Date 6/6/2016 ; Service Code 2K8963 , Lot Number 160810065C , Exp. Date 6/11/2016 ; Service Code 2K8963 , Lot Number 160820057C , Exp. Date 6/12/2016 ; Service Code 2K8963 , Lot Number 160890042C , Exp. Date 6/19/2016 ; Service Code 2K8963 , Lot Number 160950052C , Exp. Date 6/25/2016 ; Service Code 2K8963 , Lot Number 160950187M , Exp. Date 6/25/2016 ; Service Code 2K8976 , Lot Number 160470034C , Exp. Date 5/8/2016 ; Service Code 2K8976 , Lot Number 160840015C , Exp. Date 6/14/2016 ; Service Code 2K8976 , Lot Number 160880064C , Exp. Date 6/18/2016 ; Service Code 2K9285 , Lot Number 160450032C , Exp. Date 5/9/2016 ; Service Code 2K9285 , Lot Number 160520065C , Exp. Date 5/16/2016 ; Service Code 2K9285 , Lot Number 160630020C , Exp. Date 5/27/2016 ; Service Code 2K9285 , Lot Number 160690030C , Exp. Date 6/2/2016 ; Service Code 2K9285 , Lot Number 160770036C , Exp. Date 6/10/2016 ; Service Code 2K9285 , Lot Number 160840031C , Exp. Date 6/17/2016 ; Service Code 2K9285 , Lot Number 160880075C , Exp. Date 6/21/2016 ;

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: E-Mail
Type: Voluntary: Firm initiated
Address: 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506

Distribution

Quantity: 5,727 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-1416-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.