The Recall Desk
SevereFDA (Drugs)·D-1378-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

PharMEDium Services is recalling 65 bags of compounded fentanyl and bupivacaine injectable solution because glass particulate was found in the active pharmaceutical ingredient.

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, which poses a significant risk of injury.

Plain-English summary

PharMEDium Services, LLC is recalling 65 bags of 10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in Memphis, Tennessee, and distributed nationwide. The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate.

The affected product is identified by NDC 61553-143-50. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring in May and June 2016. The agency has classified this recall as Class II.

Healthcare providers and patients should stop using the affected product and contact their pharmacist or the recalling firm for further instructions. The presence of particulate matter in sterile injectable drugs poses a risk of harm to patients.

The recalled product

Product
10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-143-50
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
65

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 (13)

  • Service Code 2H8143
  • Lot Number 160830115M
  • Exp. Date 6/22/2016
  • Lot Number 160910155M
  • Exp. Date 6/30/2016
  • Service Code 2K8448
  • Lot Number 160480205M
  • Exp. Date 5/12/2016
  • Lot Number 160610064M
  • Exp. Date 5/24/2016
  • Lot Number 160760042M
  • Exp. Date 6/9/2016
  • Lot Number 160890047M

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 →

Related recalls

Same manufacturer · Pharmedium Services, LLC

See all →

Same hazard · particulate matter

See all →