The Recall Desk
HighFDA (Drugs)·D-0450-2017·Announced 2017-02-08

Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures

Dr. Reddy's is recalling Flucanazole tablets that failed dissolution and stability specifications. Patients should stop using the affected lots and consult their healthcare provider.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II due to failure of dissolution and stability specifications, which poses a risk of harm but is not classified as Class I (reasonable probability of serious adverse health consequences or death).

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Flucanazole Tablets, USP, 100 mg, in 30-count and 100-count bottles. The recall is due to the product failing dissolution specifications and an 18-month stability time point. The affected products are prescription-only and were distributed nationwide.

The specific lots involved are 30-count bottles with codes C500224 (exp 12/2016) and C500846 (exp 01/2017), and 100-count bottles with codes C500224 (exp 12/2016), C501608 (exp 02/2017), and C503655 (exp 04/2017). The total quantity recalled is 42,984 30-count bottles and 7,764 100-count bottles.

Patients who have these specific lots should stop using them and consult their healthcare provider for an alternative treatment. The FDA has classified this recall as Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

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 (7)

  • a) 30 count C500224
  • exp 12/2016
  • C500846
  • exp 01/2017 b) 100 count C500224
  • C501608
  • exp 02/2017 and C503655
  • exp 04/2017

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 →

Related recalls

Same brand · FLUCONAZOLE

Same manufacturer · Dr. Reddy's Laboratories, Inc.

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Same hazard · dissolution failure

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