The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1415-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

PharMEDium Services is recalling 1,470 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 a sterile injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

PharMEDium Services, LLC is recalling 1,470 bags of 3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The affected products are sterile injectable drugs compounded in 250 mL and 150 mL bags. The recall is being conducted because the active pharmaceutical ingredient (API) used to produce the drugs was contaminated with glass particulate matter.

The recalled products were distributed nationwide. Specific lot numbers and expiration dates are listed in the agency's recall notice, covering service codes 2H8239, 2K8239, and 2K8284. The products are prescription-only (Rx Only) and were compounded by PharMEDium Services, LLC in Memphis, TN.

Healthcare facilities and patients should stop using the affected lots immediately. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates provided in the official recall notice and contact PharMEDium Services or the FDA for further instructions on disposal or replacement.

The recalled product

Product
3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
1,470

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 2H8239
  • Lot Number 160400232M
  • Exp. Date 5/10/2016
  • Lot Number 160630193M
  • Exp. Date 6/2/2016
  • Service Code 2K8239
  • Lot Number 160520143M
  • Exp. Date 5/16/2016
  • Lot Number 160530306M
  • Exp. Date 5/17/2016
  • Lot Number 160610250M
  • Exp. Date 5/25/2016
  • Lot Number 160630167M
  • Exp. Date 5/27/2016
  • Lot Number 160680214M
  • Exp. Date 6/1/2016
  • Lot Number 160750241M
  • Exp. Date 6/8/2016
  • Lot Number 160820181M
  • Exp. Date 6/15/2016

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 →

Related recalls

Same manufacturer · Pharmedium Services, LLC

See all →

Same hazard · glass particulate

See all →

Similar recalls