The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1042-2016·Announced 2016-06-29

Profarma Recalls Vermox Tablets Due to Manufacturing Deviations

Profarma Distributors LLC is recalling 254 boxes of Vermox Tablets 500 mg due to CGMP deviations. The recall is voluntary and nationwide.

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 due to CGMP deviations, which typically indicates a risk of temporary or medically reversible adverse health consequences, fitting the Moderate severity criteria for voluntary precautionary recalls without reported illness.

Plain-English summary

Profarma Distributors LLC is voluntarily recalling 254 boxes of VERMOX Tablets 500 mg, 1-count box, UPC 501109900596. The recall was initiated on May 11, 2016, and is classified as Class II by the FDA. The affected product is identified by Lot # UJE 040 with an expiration date of 02/17.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The product was distributed nationwide. The recall was initiated by the firm and was terminated on January 24, 2017.

Consumers who have this product should stop using it and contact Profarma Distributors LLC for further instructions. The recall is voluntary and was initiated by the firm.

The recalled product

Product
VERMOX Tablets 500 mg, 1-count box, UPC 501109900596
Manufacturer
Profarma Distributors LLC
Category
Drug — Antiparasitic
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 (2)

  • Lot # UJE 040
  • Exp. 02/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Profarma Distributors 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 5 products in this recall →

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