The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1392-2016·Announced 2016-07-27

FDA Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulate

PharMEDium Services is recalling 950 bags of compounded fentanyl and bupivacaine infusions because glass particulate was found in the active pharmaceutical ingredient.

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 involves a Class II FDA classification for a sterile injectable drug contaminated with glass particulate, which poses a significant risk of injury consistent with the 'Severe' rubric criteria.

Plain-English summary

PharMEDium Services, LLC is recalling 950 bags of 2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The affected products are available in 130 mL and 200 mL volumes and were distributed nationwide. The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate.

The recall covers specific lots of the 130 mL bags (Service Code 2K9226) and 200 mL bags (Service Code 2K9294) with expiration dates ranging from May 9, 2016, to June 27, 2016. The products are prescription-only and were compounded by PharMEDium Services, LLC in Memphis, Tennessee.

Healthcare providers and patients should discontinue use of the affected lots and contact PharMEDium Services for further instructions. 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.

The recalled product

Product
2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only, Compounded by…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
950

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 2K9226
  • Lot Number 160450145M
  • Exp. Date 5/9/2016
  • Lot Number 160530166M
  • Exp. Date 5/17/2016
  • Lot Number 160560080M
  • Exp. Date 5/19/2016
  • Lot Number 160670164M
  • Exp. Date 5/31/2016
  • Lot Number 160730130M
  • Exp. Date 6/6/2016
  • Lot Number 160770032M
  • Exp. Date 6/10/2016
  • Lot Number 160810035M
  • Exp. Date 6/13/2016
  • Lot Number 160820135M
  • Exp. Date 6/15/2016
  • Lot Number 160870152M
  • Exp. Date 6/20/2016
  • Lot Number 160890036M

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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