The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1419-2016·Announced 2016-07-27

Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates

Pharmedium Services is recalling 3,828 syringes of compounded fentanyl and bupivacaine 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 a sterile injectable drug, which poses a significant risk of injury or adverse health consequences upon administration.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 3,828 syringes of 4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in 60 mL Monoject syringes and 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 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, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should discontinue use of the affected lots immediately. The recall covers specific lots identified by Service Codes 2H8267, 2K8128, 2K8267, 2K8638, and 2K8983, with expiration dates ranging from May 11, 2016, to July 17, 2016. Users should check their inventory against the specific lot numbers and expiration dates listed in the official recall notice to determine if they are affected.

The recalled product

Product
4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
3,828

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 2H8267
  • Lot Number 160630024M
  • Exp. Date 5/28/2016
  • Service Code 2K8128
  • Lot Number 160490252M
  • Exp. Date 5/13/2016
  • Lot Number 160530274M
  • Exp. Date 5/17/2016
  • Lot Number 160600213M
  • Exp. Date 5/24/2016
  • Lot Number 160660184M
  • Exp. Date 5/30/2016
  • Lot Number 160730236M
  • Exp. Date 6/6/2016
  • Lot Number 160810218M
  • Exp. Date 6/14/2016
  • Lot Number 160820186M
  • Exp. Date 6/15/2016
  • Lot Number 160940172M
  • Exp. Date 6/27/2016

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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