FDAClass IIJuly 27, 2016

3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recall: Particulate Matter

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…

Why was 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled?

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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 ;

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…
Recalling firm
Pharmedium Services, LLC
Quantity
5,727 Medical Cassettes
Distribution
Nationwide
Recall date
July 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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