The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1423-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

PharMEDium Services is recalling 3,474 bags of sterile injectable fentanyl and bupivacaine 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 3,474 bags of 5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate.

The affected products are distributed nationwide and are available in various bag sizes, including 100 ml, 250 ml, 350 ml, and 500 ml configurations. The recall covers multiple lot numbers and service codes, with expiration dates ranging from May 2016 to July 2016.

Healthcare providers and facilities should discontinue use of the affected lots and return them to PharMEDium Services, LLC. Patients who have received these products should contact their healthcare provider for further instructions.

The recalled product

Product
5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code…
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
3,474

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 2H8136
  • Lot Number 160390196M
  • Exp. Date 5/9/2016
  • Lot Number 160400231M
  • Exp. Date 5/10/2016
  • Lot Number 160410114M
  • Exp. Date 5/11/2016
  • Lot Number 160460187M
  • Exp. Date 5/16/2016
  • Lot Number 160490237M
  • Exp. Date 5/19/2016
  • Lot Number 160520172M
  • Exp. Date 5/22/2016
  • Lot Number 160530288M
  • Exp. Date 5/23/2016
  • Lot Number 160600186M
  • Exp. Date 5/30/2016
  • Lot Number 160630207M
  • Exp. Date 6/2/2016
  • Lot Number 160670243M

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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