The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1421-2016·Announced 2016-07-27

Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulates

Pharmedium Services is recalling 2,256 cassettes of compounded Fentanyl and Bupivacaine because glass particulates were 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 recall is classified as FDA Class II and involves a structural defect (glass particulates) in a sterile injectable drug, which meets the rubric criteria for a Severe rating due to the risk of significant injury.

Plain-English summary

Pharmedium Services, LLC is recalling 2,256 cassettes of 5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded in 100 mL Yellow Smiths Medical Cassettes and is distributed nationwide.

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 have expiration dates ranging from May 7, 2016, to June 18, 2016.

Healthcare providers and patients should stop using the affected cassettes and contact Pharmedium Services or their local FDA office for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
2,256

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 160460023M
  • Exp. Date 5/7/2016
  • Lot Number 160460024M
  • Lot Number 160460025M
  • Lot Number 160460328M
  • Lot Number 160540052M
  • Exp. Date 5/15/2016
  • Lot Number 160600338M
  • Exp. Date 5/21/2016
  • Lot Number 160600339M
  • Lot Number 160600340M
  • Lot Number 160600341M
  • Lot Number 160680065C
  • Exp. Date 5/29/2016
  • Lot Number 160750039C
  • Exp. Date 6/5/2016
  • Lot Number 160750040C
  • Lot Number 160750041C
  • Lot Number 160770040C
  • Exp. Date 6/7/2016

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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