0.0625% Bupivacaine HCl recall: Particulate Matter
0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL White Smiths Medical Cassette (NDC 615530-933-11) f) 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ;
Why was 0.0625% 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 2H8197 , Lot Number 160730048M , Exp. Date 6/12/2016 ; Service Code 2H8197 , Lot Number 160840111M , Exp. Date 6/22/2016 ; Service Code 2H8197 , Lot Number 160870066M , Exp. Date 6/25/2016 ; Service Code 2H8197 , Lot Number 160880208M , Exp. Date 6/27/2016 ; Service Code 2H8197 , Lot Number 160910038M , Exp. Date 6/29/2016 ; Service Code 2K8189 , Lot Number 160730049M , Exp. Date 6/11/2016 ; Service Code 2K8189 , Lot Number 160810152M , Exp. Date 6/20/2016 ; Service Code 2K8189 , Lot Number 160820330M , Exp. Date 6/21/2016 ; Service Code 2K8189 , Lot Number 160940135M , Exp. Date 7/3/2016 ; Service Code 2K8189 , Lot Number 160960178M , Exp. Date 7/5/2016 ; Service Code 2K8189 , Lot Number 160970201M , Exp. Date 7/6/2016 ; Service Code 2K8197 , Lot Number 160660178M , Exp. Date 6/5/2016 ; Service Code 2K8197 , Lot Number 160670161M , Exp. Date 6/6/2016 ; Service Code 2K8197 , Lot Number 160730253M , Exp. Date 6/12/2016 ; Lot # 160770186M; Exp. 06/16 Lot # 160810189M; Exp. 06/16 Lot # 160840050M; Exp. 06/16 Lot # 160890231M; Exp. 06/16 Lot # 160910228M; Exp. 06/16 Lot # 160560020M; Exp. 05/16 Lot # 160610020C; Exp. 05/16 Lot # 160630014C; Exp. 06/16 Lot # 160660007C; Exp. 06/16 Lot # 160670052C; Exp. 06/16 Lot # 160680067C; Exp. 06/16 Lot # 160740037C; Exp. 06/16 Lot # 160740038C; Exp. 06/16 Lot # 160810067C; Exp. 06/16 Lot # 160840174M; Exp. 06/16 Lot # 160880157M; Exp. 06/16 Lot # 169000103M; Exp. 06/16 Lot # 160600222M; Exp. 05/16 Lot # 160740168M; Exp. 05/16 Lot # 160810051C ;Exp. 05/16 Lot # 160830031C; Exp. 06/16 Lot # 160880019C; Exp. 06/16 Lot # 160880175M; Exp. 06/16 Lot # 160950002C; Exp. 06/16 Lot # 160960172M; Exp. 07/16 Lot # 160950133M; Exp. 07/16
- Product
- 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL White Smiths Medical Cassette (NDC 615530-933-11) f) 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ;
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 2,194 bags and cassettes
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)