The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0689-2017·Announced 2017-05-10

Fluconazole Tablets Recalled for Failed Dissolution Specifications

The Harvard Drug Group is recalling 914 cartons of Fluconazole 200 mg tablets because they failed to meet required dissolution 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 2/5 (Moderate).

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 is reasonably likely to cause temporary or medically reversible health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a contamination or mislabeling of a high-risk allergen.

Plain-English summary

The Harvard Drug Group is voluntarily recalling 914 cartons of Fluconazole Tablets, USP, 200 mg. The product is distributed in 100-count Unit Dose cartons and is marked for prescription use only. The specific lot number is T-00519, with an expiration date of 01-17.

The recall was initiated because the affected tablets failed to meet established dissolution specifications. Dissolution testing ensures that a drug releases its active ingredient at the correct rate in the body. When these specifications are not met, the medication may not work as intended or may not be absorbed properly.

The recalled product was distributed nationwide within the United States. It was manufactured by Dr. Reddy's Laboratories Limited in India and distributed by Major Pharmaceuticals in Livonia, Michigan. Consumers and healthcare providers should stop using the affected lot and contact their pharmacist or healthcare provider for a replacement or refund.

The recalled product

Product
FLUCONAZOLE (FLUCONAZOLE)
Brand
FLUCONAZOLE
Manufacturer
The Harvard Drug Group
Category
Drug — Antifungal
Hazard
Affected units
914

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 (2)

  • Lot #:T-00519
  • Exp. 01-17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by The Harvard Drug Group 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 2 products in this recall →

Related recalls

Same brand · FLUCONAZOLE

Same manufacturer · The Harvard Drug Group

See all →

Same hazard · dissolution failure

See all →

Similar recalls