The Recall Desk
SevereFDA (Drugs)·D-1433-2016·Announced 2016-07-27

PharMEDium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate

PharMEDium Services, LLC is recalling 79 syringes of compounded Fentanyl Citrate and Bupivacaine HCl due to the presence of glass particulate matter in the active pharmaceutical ingredient.

What this means for you

Illness, injury, or structural failure has been reported. 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 involves a sterile injectable drug contaminated with glass particulate matter, which presents a significant risk of injury or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

PharMEDium Services, LLC is recalling 79 syringes of 6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in Memphis, Tennessee, and was distributed nationwide. The recall involves specific lots with expiration dates ranging from May 14, 2016, to June 29, 2016.

The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate matter. The presence of particulate matter in sterile injectable medications poses a risk to patient safety.

Healthcare providers and patients who have received this product should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-156-86
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
79

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 (10)

  • Lot Number 160450146M
  • Exp. Date 5/14/2016
  • Lot Number 160520168M
  • Exp. Date 5/22/2016
  • Lot Number 160620181M
  • Exp. Date 6/1/2016
  • Lot Number 160760038M
  • Exp. Date 6/14/2016
  • Lot Number 160900172M
  • 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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