The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1402-2016·Announced 2016-07-27

Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

Pharmedium Services, LLC is recalling 95 bags of compounded fentanyl and bupivacaine injectable solutions nationwide because the active ingredient was contaminated with 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 involves the presence of glass particulate matter in sterile injectable drugs, which poses a significant risk of injury or harm to patients.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 95 bags of 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The affected products are sterile injectable drugs compounded by Pharmedium Services, LLC in Memphis, TN, and were distributed nationwide.

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 Service Code 2H8103 (Lot 160450153M) and multiple lots under Service Code 2K8444 (Lots 160490047C, 160540031C, 160610039C, 160730032C, 160760038C, 160800049C, and 160960053C).

Healthcare providers and facilities that have received these products should stop using them and contact Pharmedium Services, LLC for further instructions. Patients who have received these injections should contact their healthcare provider if they have any concerns.

The recalled product

Product
2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), Rx Only, Compounded by…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
95

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 (18)

  • Service Code 2H8103
  • Lot Number 160450153M
  • Exp. Date 5/11/2016
  • Service Code 2K8444
  • Lot Number 160490047C
  • Exp. Date 5/13/2016
  • Lot Number 160540031C
  • Exp. Date 5/18/2016
  • Lot Number 160610039C
  • Exp. Date 5/25/2016
  • Lot Number 160730032C
  • Exp. Date 6/6/2016
  • Lot Number 160760038C
  • Exp. Date 6/9/2016
  • Lot Number 160800049C
  • Exp. Date 6/13/2016
  • Lot Number 160960053C
  • Exp. Date 6/29/2016

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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