The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0703-2018·Announced 2018-05-09

AuroMedics Recalls Linezolid Injection Bags Due to Sterility Concerns

AuroMedics Pharma LLC is recalling Linezolid Injection bags due to a lack of assurance of sterility and a confirmed report of leaking bags with mold.

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 involves a confirmed report of mold and leaking bags, which poses a significant risk of serious injury or infection to patients receiving intravenous medication.

Plain-English summary

AuroMedics Pharma LLC is recalling 39,515 bags of Linezolid Injection 600 mg per 300 mL (2 mg/mL) for intravenous administration. The product is manufactured by Aurobindo Pharma Limited in India for AuroMedics Pharma, LLC. The recall covers specific lot numbers with expiration dates ranging from July 2018 to October 2019.

The recall was initiated due to a lack of assurance of sterility. A confirmed customer report indicated that bags were leaking and mold was found between the outer bag and the overwrap. The affected product was distributed nationwide in the United States.

Healthcare providers and patients should stop using the affected Linezolid Injection bags immediately. The FDA classifies 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.

The recalled product

Product
LINEZOLID (LINEZOLID)
Brand
LINEZOLID
Manufacturer
AuroMedics Pharma LLC
Category
Drug — Antibiotic Injection
Hazard
Affected units
395,150

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/Batch #'s: CLZ160001
  • CLZ160002
  • CLZ160003
  • CLZ160004 exp July 2018
  • CLZ160005
  • CLZ160006
  • CLZ160008
  • CLZ160009
  • CLZ160010 and CLZ160012
  • exp August 2018
  • CLZ160013
  • CLZ160014
  • CLZ160015
  • CLZ160016
  • exp October 2018
  • CLZ160017
  • CLZ160018
  • CLZ160019
  • CLZ160021
  • CLZ160022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by AuroMedics Pharma 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 7 products in this recall →

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