The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1398-2016·Announced 2016-07-27

Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

Pharmedium Services, LLC is recalling 940 bags of compounded fentanyl and bupivacaine injectable solution 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 the hazard involves particulate contamination in a sterile injectable drug, which meets the criteria for a Severe rating due to the potential for significant injury.

Plain-English summary

Pharmedium Services, LLC is recalling 940 bags of 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded in 100 mL volumes within 150 mL Baxter Intravia Bags and is distributed nationwide. The recall involves multiple lots with expiration dates ranging from May 8, 2016, to June 28, 2016.

The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate matter. The presence of particulate matter in sterile injectable medications poses a risk to patient safety.

Healthcare providers and patients should stop using the affected lots immediately. Consumers and medical facilities should check their inventory for the specific lot numbers and expiration dates listed in the recall notice and contact Pharmedium Services, LLC or the FDA for further instructions on disposal or replacement.

The recalled product

Product
2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
940

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)

  • Lot Number 160380168M
  • Exp. Date 5/8/2016
  • Lot Number 160410137M
  • Exp. Date 5/11/2016
  • Lot Number 160460150M
  • Exp. Date 5/16/2016
  • Lot Number 160530279M
  • Exp. Date 5/23/2016
  • Lot Number 160590185M
  • Exp. Date 5/29/2016
  • Lot Number 160630160M
  • Exp. Date 6/2/2016
  • Lot Number 160680179M
  • Exp. Date 6/7/2016
  • Lot Number 160730238M
  • Exp. Date 6/12/2016
  • Lot Number 160840215M
  • Exp. Date 6/23/2016
  • Lot Number 160880193M
  • Exp. Date 6/27/2016

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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