The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1407-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

PharMEDium Services is recalling 380 bags of compounded fentanyl and bupivacaine injectable solution 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 a sterile injectable drug contaminated with glass particulates, which poses a significant risk of injury to patients.

Plain-English summary

PharMEDium Services, LLC is recalling 380 bags of 2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in 250 mL Baxter Intravia bags. The recall was initiated because the active pharmaceutical ingredient (API) used to produce the drug was contaminated with glass particulate matter.

The affected product is distributed nationwide. The recall covers specific lots with expiration dates ranging from May 17, 2016, to June 29, 2016. The specific lot numbers are 160530277M, 160610199M, 160660176M, 160690200M, 160770187M, 160890268M, and 160960227M.

Healthcare providers and patients should stop using the affected product immediately. The presence of glass particulates in a sterile injectable drug poses a risk of injury if administered. Consumers and healthcare facilities should contact PharMEDium Services or their local FDA office for further instructions on how to return or dispose of the product.

The recalled product

Product
2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8297, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-297-02
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
380

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 (14)

  • Lot Number 160530277M
  • Exp. Date 5/17/2016
  • Lot Number 160610199M
  • Exp. Date 5/25/2016
  • Lot Number 160660176M
  • Exp. Date 5/30/2016
  • Lot Number 160690200M
  • Exp. Date 6/2/2016
  • Lot Number 160770187M
  • Exp. Date 6/10/2016
  • Lot Number 160890268M
  • Exp. Date 6/22/2016
  • Lot Number 160960227M
  • 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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