The Recall Desk
SevereFDA (Drugs)·D-1432-2016·Announced 2016-07-27

Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates

Pharmedium Services, LLC is recalling 180 syringes of compounded Fentanyl Citrate and Bupivacaine HCl because the active ingredient was contaminated with 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of injury from glass particulates in a sterile injectable drug.

Plain-English summary

Pharmedium Services, LLC is recalling 180 syringes of 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded in 15 mL volumes within 20 mL BD Syringes and is identified by NDC 61553-993-86.

The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate matter. The affected lots include 160480035C, 160560026C, 160620029C, 160630001C, 160810283M, 160880013C, and 160890043C, with expiration dates ranging from May 18, 2016, to June 28, 2016.

The product was distributed nationwide. Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or a return.

The recalled product

Product
6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-993-86
Manufacturer
Pharmedium Services, LLC
Category
Drug — Compounded Injectable
Hazard
Affected units
180

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 (13)

  • Lot Number 160480035C
  • Exp. Date 5/18/2016
  • Lot Number 160560026C
  • Exp. Date 5/26/2016
  • Lot Number 160620029C
  • Exp. Date 6/1/2016
  • Lot Number 160630001C
  • Lot Number 160810283M
  • Exp. Date 6/20/2016
  • Lot Number 160880013C
  • Exp. Date 6/27/2016
  • Lot Number 160890043C
  • Exp. Date 6/28/2016

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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Same hazard · glass particulate

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