The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1374-2016·Announced 2016-07-27

Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

Pharmedium Services, LLC is recalling 361 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, and the presence of glass particulates in a sterile injectable drug poses a significant risk of serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Pharmedium Services, LLC is recalling 361 bags of 1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in 150 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 identified by NDC 61553-032-95 and Service Code 2K9232. The recall covers ten specific lot numbers with expiration dates ranging from May 10, 2016, to July 11, 2016. The product was distributed nationwide. The source text does not specify the number of reported illnesses or injuries associated with this recall.

Healthcare providers and patients should stop using the affected lots of this compounded medication. Consumers should check their medication packaging for the NDC, lot number, and expiration date to determine if they have the recalled product. If the product matches the recalled lots, it should be returned to the pharmacy or healthcare provider for disposal or replacement.

The recalled product

Product
1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9232, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-032-95
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Compounded Medication
Hazard
Affected units
361

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 160460204M
  • Exp. Date 5/10/2016
  • Lot Number 160560170M
  • Exp. Date 5/20/2016
  • Lot Number 160700007M
  • Exp. Date 6/2/2016
  • Lot Number 160810176M
  • Exp. Date 6/14/2016
  • Lot Number 160830325M
  • Exp. Date 6/16/2016
  • Lot Number 160880270M
  • Exp. Date 6/21/2016
  • Lot Number 160890245M
  • Exp. Date 6/22/2016
  • Lot Number 160900144M
  • Exp. Date 6/23/2016
  • Lot Number 160950241M
  • Exp. Date 6/28/2016
  • Lot Number 161080135M
  • Exp. Date 7/11/2016

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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