The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1389-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulates

PharMEDium Services is recalling 425 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of 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 presence of glass particulates in sterile injectable drugs poses a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

PharMEDium Services, LLC is recalling 425 bags of 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded in 150 mL Baxter Intravia Bags and is available by prescription only. The recall covers specific lots with expiration dates ranging from May 9, 2016, to July 5, 2016.

The recall was initiated 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.

Healthcare providers and patients should stop using the affected lots immediately. Consumers should check their medication packaging for the specific lot numbers and expiration dates listed in the recall notice and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8103, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-103-48
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
425

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 160390174M
  • Exp. Date 5/9/2016
  • Lot Number 160400196M
  • Exp. Date 5/10/2016
  • Lot Number 160470128M
  • Exp. Date 5/17/2016
  • Lot Number 160530287M
  • Exp. Date 5/23/2016
  • Lot Number 160540190M
  • Exp. Date 5/24/2016
  • Lot Number 160590168M
  • Exp. Date 5/29/2016
  • Lot Number 160610129M
  • Exp. Date 5/31/2016
  • Lot Number 160680254M
  • Exp. Date 6/7/2016
  • Lot Number 160700199M
  • Exp. Date 6/9/2016
  • Lot Number 160750132M
  • Exp. Date 6/14/2016

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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