The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1394-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates

PharMEDium Services is recalling 1,280 cassettes of compounded fentanyl and bupivacaine infusions 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. Under the severity rubric, an FDA Class II recall involving a sterile injectable drug contaminated with particulate matter (glass) is categorized as Severe (Score 4) due to the potential for significant injury, even without reported cases.

Plain-English summary

PharMEDium Services, LLC is recalling 1,280 medical cassettes of 2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall involves 100 mL and 250 mL volumes in Yellow Smiths Medical Cassettes. The products were 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 source text does not report any illnesses or injuries associated with this contamination.

Healthcare facilities and patients who have received these specific lots should contact their healthcare provider for guidance. The recall covers specific lot numbers and expiration dates listed in the official FDA notice, including lots expiring between May and July 2016.

The recalled product

Product
2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), Rx…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Compounded Injectable
Hazard
Affected units
1,280

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 2K8176
  • Lot Number 160460099M
  • Exp. Date 5/10/2016
  • Lot Number 160480269M
  • Exp. Date 5/12/2016
  • Lot Number 160560160M
  • Exp. Date 5/20/2016
  • Lot Number 160630171M
  • Exp. Date 5/27/2016
  • Lot Number 160690141M
  • Exp. Date 6/2/2016
  • Lot Number 160740128M
  • Exp. Date 6/7/2016
  • Lot Number 160750247M
  • Exp. Date 6/8/2016
  • Lot Number 160810137M
  • Exp. Date 6/14/2016
  • Lot Number 160870187M
  • Exp. Date 6/20/2016
  • Lot Number 160940253M

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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