The Recall Desk
SevereFDA (Drugs)·D-1380-2016·Announced 2016-07-27

Pharmedium Recalls Fentanyl and Bupivacaine Injectable Due to Glass Particulate

Pharmedium Services, LLC is recalling specific lots of compounded Fentanyl Citrate and Bupivacaine HCl injectable solutions because they were produced using an API contaminated with glass particulate matter.

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 is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The presence of glass particulate in a sterile injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling specific lots of 10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag. The recall is being conducted because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate matter.

The affected product is a prescription-only compounded medication. The recall covers 17 specific lot numbers with expiration dates ranging from May 10, 2016, to June 30, 2016. The distribution pattern for these products is listed as nationwide.

Healthcare providers and patients should discontinue use of the affected lots and return them to the pharmacy or supplier for disposal. Consumers should check their medication packaging for the specific lot numbers and expiration dates listed in the recall notice to determine if their product is affected.

The recalled product

Product
10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard

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 160460189M
  • Exp. Date 5/10/2016
  • Lot Number 160480179M
  • Exp. Date 5/12/2016
  • Lot Number 160520105M
  • Exp. Date 5/15/2016
  • Lot Number 160530291M
  • Exp. Date 5/17/2016
  • Lot Number 160540130M
  • Lot Number 160550186M
  • Exp. Date 5/19/2016
  • Lot Number 160560087M
  • Lot Number 160590074M
  • Exp. Date 5/23/2016
  • Lot Number 160620037M
  • Exp. Date 5/25/2016
  • Lot Number 160630028M
  • Exp. Date 5/26/2016
  • Lot Number 160660039M
  • Exp. Date 5/29/2016

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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