The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1425-206·Announced 2016-07-27

FDA Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate Matter

PharMEDium Services is recalling 2,713 syringes of compounded fentanyl and bupivacaine 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 or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the presence of glass particulate in a sterile injectable drug poses a significant risk of injury, aligning with the Severe criteria for significant injury reports or high-risk contamination.

Plain-English summary

PharMEDium Services, LLC is recalling 2,713 syringes of 5 mcg/mL Fentanyl Citrate and 0.1% 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 matter.

The affected products are prescription-only compounded medications distributed nationwide. The recall covers multiple lot numbers and service codes, including 2T6257, 2H8138, 2K8138, 2K8807, 2K8872, 2K9138, and 2T8141, with expiration dates ranging from May 2016 to July 2016.

Healthcare providers and patients should stop using the affected syringes and contact PharMEDium Services or their local FDA office for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
2,713

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 2H8138
  • Lot Number 160410192M
  • Exp. Date 5/11/2016
  • Lot Number 160600314M
  • Exp. Date 5/30/2016
  • Lot Number 160690002M
  • Exp. Date 6/7/2016
  • Lot Number 160690191M
  • Exp. Date 6/8/2016
  • Lot Number 160740233M
  • Exp. Date 6/13/2016
  • Lot Number 160760163M
  • Exp. Date 6/14/2016
  • Lot Number 160830226M
  • Exp. Date 6/22/2016
  • Lot Number 160890256M
  • Exp. Date 6/28/2016
  • Lot Number 160940138M
  • Exp. Date 7/3/2016
  • Lot Number 160960197M

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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