The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1377-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate

PharMEDium Services, LLC is recalling 384 cassettes of Fentanyl Citrate and Bupivacaine HCl 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 FDA classified this as a Class II recall. The presence of glass particulate in a sterile injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

PharMEDium Services, LLC is recalling 384 medical cassettes of 1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall involves two service codes: 2T8232 (250 ml cassettes) and 2T8878 (100 ml cassettes). The products were compounded in Memphis, TN, and 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 specific lot numbers and expiration dates for the affected units are listed in the source metadata.

Healthcare facilities and consumers should stop using the affected cassettes immediately and contact PharMEDium Services, LLC for further instructions or a return. The FDA has classified this as a Class II recall.

The recalled product

Product
1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
384

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 2T8232
  • Lot Number 160970019C
  • Exp. Date 5/7/2016
  • Service Code 2T8878
  • Lot Number 160450193M
  • Exp. Date 5/6/2016
  • Lot Number 160470227M
  • Exp. Date 5/8/2016
  • Lot Number 160590187M
  • Exp. Date 5/19/2016
  • Lot Number 160630026M
  • Exp. Date 5/23/2016
  • Lot Number 160700162M
  • Exp. Date 5/31/2016
  • Lot Number 160710004M
  • Lot Number 160740228M
  • Exp. Date 6/4/2016
  • Lot Number 160750111M
  • Lot Number 160900226M
  • Exp. Date 6/20/2016

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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