The Recall Desk
SevereFDA (Drugs)·D-1393-2016·Announced 2016-07-27

Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

Pharmedium Services is recalling 1,476 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 particulate in sterile injectable drugs poses a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

Pharmedium Services, LLC is recalling 1,476 bags of 2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The affected products are sterile injectable drugs compounded by Pharmedium Services in Memphis, TN, and were distributed nationwide. The recall involves specific lots of the drug packaged in Hospira LifeCare and Baxter Intravia bags, with expiration dates ranging from May 8, 2016, to July 13, 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 presence of particulate matter in sterile injectable medications poses a risk to patients who receive the drug.

Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be removed from use and returned to the distributor or the recalling firm. Consumers should not use the recalled product and should contact their healthcare provider for further instructions.

The recalled product

Product
2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8296 (NDC 61553-296-52), 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8296 (NDC 61553-296-22), Rx Only, Compounded by Ph
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
1,476

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 2H8296
  • Lot Number 160420192M
  • Exp. Date 5/8/2016
  • Lot Number 160450199M
  • Exp. Date 5/11/2016
  • Lot Number 160490146M
  • Exp. Date 5/15/2016
  • Lot Number 160590180M
  • Exp. Date 5/25/2016
  • Lot Number 160660231M
  • Exp. Date 6/1/2016
  • Lot Number 160700136M
  • Exp. Date 6/5/2016
  • Lot Number 160770233M
  • Exp. Date 6/12/2016
  • Lot Number 160820140M
  • Exp. Date 6/17/2016
  • Lot Number 160880282M
  • Exp. Date 6/23/2016
  • Lot Number 160910131M

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 →