The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1418-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

PharMEDium Services is recalling 455 bags of compounded fentanyl and bupivacaine injectable solutions distributed nationwide. The recall is due to the presence of glass particulate matter in the active pharmaceutical ingredient.

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 particulates in sterile injectable drugs, which poses a significant risk of injury or adverse health consequences.

Plain-English summary

PharMEDium Services, LLC is recalling 455 bags of 4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The affected products are sterile injectable drugs compounded in 250 mL Hospira LifeCare Bags and 125 mL Baxter Intravia Bags. The recall covers specific lot numbers and expiration dates ranging from May 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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected products were distributed nationwide. Healthcare providers and patients who have received or used these specific lots of compounded fentanyl and bupivacaine solutions should stop using them and contact their pharmacist or healthcare provider for further instructions.

The recalled product

Product
4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Compounded Injectable
Hazard
Affected units
455

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 2H8126
  • Lot Number 161080146M
  • Exp. Date 7/17/2016
  • Service Code 2K8127
  • Lot Number 160460115M
  • Exp. Date 5/10/2016
  • Lot Number 160560222M
  • Exp. Date 5/20/2016
  • Lot Number 160610209M
  • Exp. Date 5/25/2016
  • Lot Number 160620148M
  • Exp. Date 5/26/2016
  • Lot Number 160660062M
  • Exp. Date 5/29/2016
  • Lot Number 160680154M
  • Exp. Date 6/1/2016
  • Lot Number 160690126M
  • Exp. Date 6/2/2016
  • Lot Number 160740153M
  • Exp. Date 6/7/2016

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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