The Recall Desk
SevereFDA (Drugs)·D-1417-2016·Announced 2016-07-27

Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

Pharmedium Services, LLC is recalling 1,015 bags of compounded fentanyl and bupivacaine injectable solutions because the active ingredient was 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 and involves a sterile injectable drug contaminated with glass particulate matter, which poses a significant risk of injury.

Plain-English summary

Pharmedium Services, LLC is recalling 1,015 bags of 3.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded in 125 mL volumes within 150 mL Baxter Intravia Bags and is distributed nationwide. The recall is identified by FDA recall number D-1417-2016.

The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate matter. The affected lots include nine specific lot numbers with expiration dates ranging from May 9, 2016, to July 6, 2016.

Healthcare providers and patients should stop using the affected product immediately. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled medication.

The recalled product

Product
3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
1,015

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 (17)

  • Lot Number 160390336M
  • Exp. Date 5/9/2016
  • Lot Number 160530318M
  • Exp. Date 5/23/2016
  • Lot Number 160600347M
  • Exp. Date 5/30/2016
  • Lot Number 160750243M
  • Exp. Date 6/14/2016
  • Lot Number 160760164M
  • Lot Number 160830228M
  • Exp. Date 6/22/2016
  • Lot Number 160890224M
  • Exp. Date 6/28/2016
  • Lot Number 160960242M
  • Exp. Date 7/5/2016
  • Lot Number 160970140M
  • Exp. Date 7/6/2016

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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