The Recall Desk
SevereFDA (Drugs)·D-1414-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

PharMEDium Services is recalling 345 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of 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 the presence of glass particulates in sterile injectable drugs represents a significant injury risk, meeting the criteria for a Severe rating.

Plain-English summary

PharMEDium Services, LLC is recalling 345 bags of compounded sterile injectable drugs containing 3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl. The affected products are available in 100 mL and 250 mL volumes in Hospira LifeCare and Baxter Intravia bags. The recall covers specific lots distributed nationwide, with expiration dates ranging from May 2016 to July 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 presence of particulate matter in sterile injectable solutions poses a risk to patients who receive the medication.

Healthcare facilities and patients who have received these specific products should contact their healthcare provider or the recalling firm for further instructions. Consumers should not use the recalled products and should check their inventory for the specific service codes and lot numbers listed in the recall notice.

The recalled product

Product
3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL Baxte
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
345

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 2H8180
  • Lot Number 160450152M
  • Exp. Date 5/11/2016
  • Lot Number 160830040M
  • Exp. Date 6/17/2016
  • Service Code 2H8262
  • Lot Number 160380102M
  • Exp. Date 5/8/2016
  • Lot Number 160750131M
  • Exp. Date 6/14/2016
  • Lot Number 161080121M
  • Exp. Date 7/17/2016
  • Service Code 2K8180
  • Lot Number 160460038C
  • Exp. Date 5/10/2016
  • Lot Number 160480026C
  • Exp. Date 5/12/2016
  • Lot Number 160550022C
  • Exp. Date 5/19/2016
  • Lot Number 160620021C

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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