The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1413-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

PharMEDium Services is recalling 700 bags of compounded fentanyl and bupivacaine injectable solution 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, which involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The presence of glass particulate in a sterile injectable drug represents a significant injury risk.

Plain-English summary

PharMEDium Services, LLC is recalling 700 bags of 3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in 250 mL Baxter Intravia bags. The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate matter.

The affected product is distributed nationwide. The recall covers specific lots with expiration dates ranging from May 6, 2016, to June 27, 2016. The specific lot numbers and expiration dates are: 160420248M (5/6/2016), 160490250M (5/13/2016), 160600329M (5/24/2016), 160620002M (5/25/2016), 160660181M (5/30/2016), 160760025M (6/9/2016), 160870159M (6/20/2016), and 160940170M (6/27/2016).

Healthcare providers and patients should stop using the affected product immediately. The presence of glass particulate matter in a sterile injectable drug poses a risk of injury if administered. Consumers and healthcare facilities should contact PharMEDium Services, LLC for further instructions on returning or disposing of the recalled product.

The recalled product

Product
3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Solution
Hazard
Affected units
700

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 (16)

  • Lot Number 160420248M
  • Exp. Date 5/6/2016
  • Lot Number 160490250M
  • Exp. Date 5/13/2016
  • Lot Number 160600329M
  • Exp. Date 5/24/2016
  • Lot Number 160620002M
  • Exp. Date 5/25/2016
  • Lot Number 160660181M
  • Exp. Date 5/30/2016
  • Lot Number 160760025M
  • Exp. Date 6/9/2016
  • Lot Number 160870159M
  • Exp. Date 6/20/2016
  • Lot Number 160940170M
  • Exp. Date 6/27/2016

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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