The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1406-2016·Announced 2016-07-27

Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate

Pharmedium Services, LLC is recalling 220 cassettes of compounded fentanyl and bupivacaine injectable drugs because the active ingredient was contaminated with glass particulate.

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 the presence of glass particulate in sterile injectable drugs poses a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

Pharmedium Services, LLC is recalling 220 medical cassettes of 2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall is due to the presence of particulate matter, specifically glass particulate, in the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs.

The affected products are distributed nationwide. The recall includes specific lots with Service Codes 2K8210 and 2K8972, with expiration dates ranging from May 6, 2016, to June 27, 2016. The products are compounded by Pharmedium Services, LLC in Memphis, TN.

Healthcare providers and consumers should stop using the affected cassettes and contact Pharmedium Services, LLC for further instructions or a refund.

The recalled product

Product
2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow stop free flow protection, Service Code 2K8972, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
220

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 2K8210
  • Lot Number 160390175M
  • Exp. Date 5/9/2016
  • Lot Number 160400226M
  • Exp. Date 5/10/2016
  • Lot Number 160520170M
  • Exp. Date 5/22/2016
  • Lot Number 160590066M
  • Exp. Date 5/29/2016
  • Lot Number 160670046M
  • Exp. Date 6/5/2016
  • Lot Number 160680006M
  • Exp. Date 6/6/2016
  • Lot Number 160700027M
  • Exp. Date 6/8/2016
  • Lot Number 160730069M
  • Exp. Date 6/11/2016
  • Lot Number 160880217M
  • Exp. Date 6/27/2016
  • Service Code 2K8972

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 →

Related recalls

Same manufacturer · Pharmedium Services, LLC

See all →

Same hazard · glass particulate

See all →

Similar recalls