The Recall Desk
SevereFDA (Drugs)·D-1391-2016·Announced 2016-07-27

FDA Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

PharMEDium Services is recalling 17,990 bags of compounded fentanyl and bupivacaine injectable solutions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a sterile injectable drug contaminated with glass particulate, which poses a significant risk of serious injury or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

PharMEDium Services, LLC is recalling 17,990 bags of 2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in 150 mL Baxter Intravia bags. The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate.

The affected product is distributed nationwide. The recall covers multiple lot numbers and service codes, with expiration dates ranging from May 2016 to July 2016. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected lots of this compounded injectable solution. Users should check their inventory against the specific lot numbers and service codes listed in the official recall notice to identify affected units. If you have questions about this recall, contact the recalling firm, PharMEDium Services, LLC, or your local FDA office.

The recalled product

Product
2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Solution
Hazard
Affected units
17,990

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 2K9966
  • Lot Number 160390021M
  • Exp. Date 5/9/2016
  • Lot Number 160450151M
  • Exp. Date 5/15/2016
  • Lot Number 160610223M
  • Exp. Date 5/31/2016
  • Lot Number 160660080M
  • Exp. Date 6/5/2016
  • Lot Number 160880210M
  • Exp. Date 6/27/2016
  • Lot Number 160890277M
  • Exp. Date 6/28/2016
  • Lot Number 160910004M
  • Exp. Date 6/29/2016
  • Service Code 3V8709
  • Lot Number 160550119M
  • Exp. Date 5/19/2016
  • Lot Number 160630116M
  • Exp. Date 5/27/2016

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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Same hazard · glass particulate

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