The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1400-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

PharMEDium Services, LLC is recalling 480 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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the presence of glass particulate in a sterile injectable drug presents a significant risk of harm, aligning with the Severe criteria for Class II drug recalls with potential for serious adverse consequences.

Plain-English summary

PharMEDium Services, LLC is voluntarily recalling 480 bags of 2 mcg/mL Fentanyl Citrate and 0.167% 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 is due to the presence of particulate matter, specifically glass particulate, which contaminated the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs.

The affected lots were distributed nationwide. The specific lot numbers and expiration dates involved in this recall are 160480033C (Exp. 5/12/2016), 160520027C (Exp. 5/16/2016), 160610040C (Exp. 5/25/2016), 160750051C (Exp. 6/8/2016), 160800038C (Exp. 6/13/2016), 160880045C (Exp. 6/21/2016), 160940037C (Exp. 6/27/2016), and 160960035C (Exp. 6/29/2016).

Healthcare providers and patients should stop using these specific lots of the compounded medication. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9276, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-276-98
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
480

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 160480033C
  • Exp. Date 5/12/2016
  • Lot Number 160520027C
  • Exp. Date 5/16/2016
  • Lot Number 160610040C
  • Exp. Date 5/25/2016
  • Lot Number 160750051C
  • Exp. Date 6/8/2016
  • Lot Number 160800038C
  • Exp. Date 6/13/2016
  • Lot Number 160880045C
  • Exp. Date 6/21/2016
  • Lot Number 160940037C
  • Exp. Date 6/27/2016
  • Lot Number 160960035C
  • Exp. Date 6/29/2016

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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