The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1422-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

PharMEDium Services is recalling 655 bags of compounded fentanyl and bupivacaine injectable solutions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves glass particulate matter in a sterile injectable drug, which poses a significant risk of injury.

Plain-English summary

PharMEDium Services, LLC is recalling 655 bags of 5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded in 250 mL Hospira LifeCare Bags and is available by prescription only. The recall is being conducted because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate matter.

The affected products were distributed nationwide. The recall includes multiple lot numbers associated with Service Codes 2H8256, 2K8254, and 2K8256, with expiration dates ranging from May 9, 2016, to June 29, 2016. The specific NDC for the product is 61553-256-50.

Healthcare providers and patients should stop using the affected lots of this medication. Users should check their inventory against the specific lot numbers and expiration dates 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 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
655

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 2H8256
  • Lot Number 160410124M
  • Exp. Date 5/11/2016
  • Lot Number 160560146M
  • Exp. Date 5/26/2016
  • Lot Number 160590041M
  • Exp. Date 5/29/2016
  • Lot Number 160690131M
  • Exp. Date 6/8/2016
  • Lot Number 160900157M
  • Exp. Date 6/29/2016
  • Service Code 2K8254
  • Lot Number 160390176M
  • Exp. Date 5/9/2016
  • Lot Number 160410129M
  • Lot Number 160460130M
  • Exp. Date 5/16/2016
  • Lot Number 160530293M
  • Exp. Date 5/23/2016
  • Lot Number 160590075M

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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