The Recall Desk
SevereFDA (Drugs)·D-1424-2016·Announced 2016-07-27

Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

Pharmedium Services, LLC is recalling 562 bags of sterile injectable fentanyl and bupivacaine due to the presence of glass particulate matter.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall involving a sterile injectable drug contaminated with glass particulate matter, which poses a significant risk of injury or adverse health consequences.

Plain-English summary

Pharmedium Services, LLC is recalling 562 bags of 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The affected products are sterile injectable drugs packaged in 250 mL Hospira LifeCare Bags and Baxter Intravia Bags. The recall is being conducted because the active pharmaceutical ingredient (API) used to produce the drugs was contaminated with glass particulate matter.

The affected products were distributed nationwide. The recall includes specific lots identified by Service Codes 2H8287, 2K8287, 2K8811, and 2K8873, with expiration dates ranging from May 9, 2016, to July 6, 2016. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should stop using the affected lots immediately. Consumers and healthcare facilities should check their inventory for the specific lot numbers and service codes listed in the recall notice. If the product has been administered, patients should contact their healthcare provider for guidance.

The recalled product

Product
5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), Rx Only, Compounded by P
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
562

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Service Code 2H8287
  • Lot Number 160390110M
  • Exp. Date 5/9/2016
  • Lot Number 160450123M
  • Exp. Date 5/15/2016
  • Lot Number 160470115M
  • Exp. Date 5/17/2016
  • Lot Number 160600178M
  • Exp. Date 5/30/2016
  • Lot Number 160750128M
  • Exp. Date 6/14/2016
  • Lot Number 160800058M
  • Exp. Date 6/18/2016
  • Lot Number 160820110M
  • Exp. Date 6/20/2016
  • Lot Number 160960130M
  • Exp. Date 7/5/2016
  • Lot Number 160970119M
  • Exp. Date 7/6/2016
  • Service Code 2K8287

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 75 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 75 products in this recall →

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