Pharmedium Services 20 mcg/mL HYDROmorphone HCl and 0 Recall

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

20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48

Service Code 2K8158 , Lot Number 160380113M , Exp. Date 5/8/2016 ; Service Code 2K8158 , Lot Number 160410115M , Exp. Date 5/11/2016 ; Service Code 2K8158 , Lot Number 160420111M , Exp. Date 5/12/2016 ; Service Code 2K8158 , Lot Number 160450184M , Exp. Date 5/15/2016 ; Service Code 2K8158 , Lot Number 160520106M , Exp. Date 5/21/2016 ; Service Code 2K8158 , Lot Number 160530143M , Exp. Date 5/23/2016 ; Service Code 2K8158 , Lot Number 160550124M , Exp. Date 5/25/2016 ; Service Code 2K8158 , Lot Number 160560211M , Exp. Date 5/26/2016 ; Service Code 2K8158 , Lot Number 160600195M , Exp. Date 5/30/2016 ; Service Code 2K8158 , Lot Number 160620137M , Exp. Date 6/1/2016 ; Service Code 2K8158 , Lot Number 160690124M , Exp. Date 6/7/2016 ; Service Code 2K8158 , Lot Number 160730219M , Exp. Date 6/12/2016 ; Service Code 2K8158 , Lot Number 160740084C , Exp. Date 6/14/2016 ; Service Code 2K8158 , Lot Number 160770123M , Exp. Date 6/16/2016 ; Service Code 2K8158 , Lot Number 160840027M , Exp. Date 6/22/2016 ; Service Code 2K8158 , Lot Number 160870228M , Exp. Date 6/26/2016 ; Service Code 2K8158 , Lot Number 160910212M , Exp. Date 6/30/2016 ; Service Code 2K8158 , Lot Number 161080220M , Exp. Date 7/17/2016 ; Service Code 2K8495 , Lot Number 160420155M , Exp. Date 5/12/2016 ; Service Code 2K8495 , Lot Number 160490122M , Exp. Date 5/19/2016 ; Service Code 2K8913 , Lot Number 160940019C , Exp. Date 5/10/2016 ; Service Code 2K8913 , Lot Number 160960022C , Exp. Date 5/12/2016 ; Service Code 2K8913 , Lot Number 160970021C , Exp. Date 5/13/2016 ; Service Code 2K8947 , Lot Number 160970025C , Exp. Date 5/17/2016 ; Service Code 2K8986 , Lot Number 160910040M , Exp. Date 5/11/2016 ; Service Code 2T6622 , Lot Number 160950152M , Exp. Date 5/10/2016 ; Service Code 2K8495 , Lot Number 160520175M , Exp. Date 5/22/2016 ; Service Code 2K8495 , Lot Number 160530128M , Exp. Date 5/23/2016 ; Service Code 2K8495 , Lot Number 160540117M , Exp. Date 5/24/2016 ; Service Code 2K8495 , Lot Number 160550130M , Exp. Date 5/25/2016 ; Service Code 2K8495 , Lot Number 160560135M , Exp. Date 5/26/2016 ; Service Code 2K8495 , Lot Number 160610198M , Exp. Date 5/31/2016 ; Service Code 2K8495 , Lot Number 160740237M , Exp. Date 6/13/2016 ; Service Code 2K8495 , Lot Number 160750177M , Exp. Date 6/14/2016 ; Service Code 2K8495 , Lot Number 160760001M , Exp. Date 6/14/2016 ; Service Code 2K8495 , Lot Number 160820228M , Exp. Date 6/21/2016 ; Service Code 2K8495 , Lot Number 160890173M , Exp. Date 6/28/2016 ;

Nationwide

• Compare the lot number and expiration date on your package with the codes above.
• Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
• If you have symptoms you think are related, contact your doctor. In an emergency call 911.
• Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall number

D-1412-2016

Classification

Class II

Status

Terminated

Recall initiated

May 5, 2016

FDA report date

Jul 27, 2016

Quantity

555 Medical Cassettes

Recall type

Voluntary: Firm initiated

Recalling firm

Pharmedium Services, LLC