The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1382-2016·Announced 2016-07-27

FDA Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate

PharMEDium Services is recalling 740 syringes of compounded fentanyl and bupivacaine because glass particulate was found in the active 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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving potential hospitalization or significant injury risks are categorized as Severe (Score 4), particularly given the injectable nature of the product and the presence of particulate matter.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for 740 syringes of 10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded by PharMEDium Services, LLC, located in Memphis, Tennessee, and is identified by NDC 61553-203-27. The recall covers specific lots with expiration dates ranging from May 7, 2016, to July 16, 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 as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide. Healthcare providers and patients who have received or used these specific syringes should stop using them and contact their healthcare provider or the recalling firm for further instructions. Consumers should not attempt to use the product if they notice any particulate matter in the syringe.

The recalled product

Product
10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
740

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)

  • Lot Number 160380150M
  • Exp. Date 5/7/2016
  • Lot Number 160420180M
  • Exp. Date 5/11/2016
  • Lot Number 160450106M
  • Exp. Date 5/14/2016
  • Lot Number 160480109M
  • Exp. Date 5/17/2016
  • Lot Number 160660210M
  • Exp. Date 6/5/2016
  • Lot Number 160700121M
  • Exp. Date 6/8/2016
  • Lot Number 160770215M
  • Exp. Date 6/16/2016
  • Lot Number 160820099M
  • Exp. Date 6/20/2016
  • Lot Number 160880167M
  • Exp. Date 6/26/2016
  • Lot Number 161080045M
  • Exp. Date 7/16/2016

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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