The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0449-2017·Announced 2017-02-08

Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures

Dr. Reddy's Laboratories is recalling Flucanazole tablets because they failed dissolution and stability specifications.

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 source text explicitly identifies the recall as FDA Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), as they may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Flucanazole Tablets, USP, 50 mg. The recall involves 30-count and 100-count bottles manufactured in India. The specific NDC codes affected are 55111-143-30 and 55111-143-01.

The recall was initiated because the product failed dissolution specifications and an 18-month stability time point. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected products were distributed nationwide. Consumers and healthcare providers should stop using the recalled lots and contact their healthcare provider or pharmacist for guidance on alternative treatments.

The recalled product

Product
FLUCONAZOLE (FLUCONAZOLE)
Brand
FLUCONAZOLE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Antifungal
Hazard

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 (5)

  • a) 30 count C500221
  • exp 12/2016
  • C502342
  • exp 03/2017 b) 100 count C500221
  • exp 03/2017

UPCs (1)

  • 0355111145127

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Dr. Reddy's Laboratories, Inc. 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 4 products in this recall →

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