The Recall Desk
ModerateFDA (Drugs)·D-0451-2017·Announced 2017-02-08

Dr. Reddy's Recalls Flucanazole Tablets Due to Dissolution Failures

Dr. Reddy's Laboratories is recalling Flucanazole 150 mg tablets because they failed dissolution specifications and 18-month stability testing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) as it involves a potential for temporary or medically reversible adverse health consequences, but no serious injury or death is reported.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Flucanazole Tablets, USP, 150 mg, 12x1 Blister cards. The recall involves 59,440 blister cards distributed nationwide. The specific product codes are C500222, C500515, and C500517 with an expiration date of 12/2016, and C502343 with an expiration date of 03/2017. The NDC for the recalled product is 55111-145-12.

The recall was initiated because the product failed dissolution specifications and the 18-month stability time point. This is an FDA Class II recall, which indicates that violation of the Federal Food, Drug, and Cosmetic Act or other FDA regulations may or is likely to cause temporary or medically reversible adverse health consequences or that the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected Flucanazole tablets and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
FLUCONAZOLE (FLUCONAZOLE)
Brand
FLUCONAZOLE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
59,440

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 (6)

  • C500222
  • C500515
  • and C500517
  • exp 12/2016
  • C502343
  • 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 →

Related recalls

Same brand · FLUCONAZOLE

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

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Same hazard · dissolution failure

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