The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1405-2016·Announced 2016-07-27

FDA Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

PharMEDium Services is recalling 2,006 bags of compounded fentanyl and bupivacaine injectable drugs because the active ingredient was 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 involves a sterile injectable drug contaminated with glass particulate, which poses a risk of significant injury or adverse health consequences.

Plain-English summary

PharMEDium Services, LLC is recalling 2,006 bags of 2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in 200 mL Baxter Intravia bags. The recall is due to the presence of particulate matter, specifically glass particulate, which contaminated the active pharmaceutical ingredient (API) used to produce the drugs.

The affected products are distributed nationwide. The recall includes multiple lot numbers and expiration dates ranging from May 2016 to June 2016, associated with Service Codes 2H8255, 2K8255, 2K8464, and 2T8255. 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 check their inventory for the specific lot numbers and service codes listed in the recall notice. If the product is found, it should be quarantined and not administered. Patients who have received the affected product should contact their healthcare provider for guidance.

The recalled product

Product
2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
2,006

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 2H8255
  • Lot Number 160550161M
  • Exp. Date 5/11/2016
  • Lot Number 160620170M
  • Exp. Date 5/18/2016
  • Lot Number 160760132M
  • Exp. Date 6/1/2016
  • Lot Number 160830148M
  • Exp. Date 6/8/2016
  • Lot Number 160900158M
  • Exp. Date 6/15/2016
  • Lot Number 160970139M
  • Exp. Date 6/22/2016
  • Service Code 2K8255
  • Lot Number 160490046C
  • Exp. Date 5/13/2016
  • Lot Number 160620032C
  • Exp. Date 5/26/2016
  • Lot Number 160770046C
  • Exp. Date 6/10/2016

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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