2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl recall: Particulate Matter
2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,
Why was 2 mcg/mL Fentanyl Citrate and 0.25% 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 2H8103 , Lot Number 160450153M , Exp. Date 5/11/2016 ; Service Code 2K8444 , Lot Number 160490047C , Exp. Date 5/13/2016 ; Service Code 2K8444 , Lot Number 160540031C , Exp. Date 5/18/2016 ; Service Code 2K8444 , Lot Number 160610039C , Exp. Date 5/25/2016 ; Service Code 2K8444 , Lot Number 160730032C , Exp. Date 6/6/2016 ; Service Code 2K8444 , Lot Number 160760038C , Exp. Date 6/9/2016 ; Service Code 2K8444 , Lot Number 160800049C , Exp. Date 6/13/2016 ; Service Code 2K8444 , Lot Number 160960053C , Exp. Date 6/29/2016 ;
- Product
- 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 95 bags
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)