Pharmedium Services 0.2% Bupivacaine HCl Recall

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

0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, ;

Service Code 2K8119 , Lot Number 160480208M , Exp. Date 5/18/2016 ; Service Code 2K8119 , Lot Number 160490134M , Exp. Date 5/19/2016 ; Service Code 2K8119 , Lot Number 160520129M , Exp. Date 5/22/2016 ; Service Code 2K8119 , Lot Number 160530167M , Exp. Date 5/23/2016 ; Service Code 2K8119 , Lot Number 160700126M , Exp. Date 6/8/2016 ; Service Code 2K8119 , Lot Number 160740148M , Exp. Date 6/13/2016 ; Service Code 2K8119 , Lot Number 160750046M , Exp. Date 6/13/2016 ; Service Code 2K8119 , Lot Number 160820124M , Exp. Date 6/21/2016 ; Service Code 2K8171 , Lot Number 160880264M , Exp. Date 6/27/2016 ; Service Code 2K8217 , Lot Number 160380114M , Exp. Date 5/8/2016 ; Service Code 2K8217 , Lot Number 160410116M , Exp. Date 5/11/2016 ; Service Code 2K8217 , Lot Number 160480128M , Exp. Date 5/18/2016 ; Service Code 2K8217 , Lot Number 160540123M , Exp. Date 5/23/2016 ; Service Code 2K8217 , Lot Number 160600196M , Exp. Date 5/30/2016 ; Service Code 2K8217 , Lot Number 160730054M , Exp. Date 6/12/2016 ; Service Code 2K8217 , Lot Number 160740245M , Exp. Date 6/13/2016 ; Service Code 2K8217 , Lot Number 160750048M , Exp. Date 6/13/2016 ; Service Code 2K8217 , Lot Number 160840149M , Exp. Date 6/23/2016 ; Service Code 2K8217 , Lot Number 160900131M , Exp. Date 6/29/2016 ; Service Code 2K8217 , Lot Number 160960139M , Exp. Date 7/5/2016 ; Service Code 2K8463 , Lot Number 160400227M , Exp. Date 5/10/2016 ; Service Code 2K8463 , Lot Number 160630030M , Exp. Date 6/1/2016 ; Service Code 2K8463 , Lot Number 160890243M , Exp. Date 6/28/2016 ; Service Code 2K8463 , Lot Number 160970195M , Exp. Date 7/6/2016 ; Service Code 2K8931 , Lot Number 160970018C , Exp. Date 5/7/2016 ; Service Code 2N1119 , Lot Number 160490041C , Exp. Date 5/19/2016 ;

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-1367-2016

Classification

Class II

Status

Terminated

Recall initiated

May 5, 2016

FDA report date

Jul 27, 2016

Quantity

355 bags

Recall type

Voluntary: Firm initiated

Recalling firm

Pharmedium Services, LLC