The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1041-2016·Announced 2016-06-29

Profarma Recalls Vermox Tablets Due to Manufacturing Deviations

Profarma Distributors LLC is recalling 163 boxes of Vermox Tablets 100 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, which is a reasonable probability of temporary or medically reversible adverse health consequences. The source cites CGMP deviations without reporting specific illnesses or injuries, fitting the criteria for a moderate severity voluntary recall.

Plain-English summary

Profarma Distributors LLC is voluntarily recalling 163 boxes (978 tablets) of VERMOX Tablets 100 mg, 6-count boxes. The specific lot number is UPE187 with an expiration date of 08/17. The product was distributed nationwide.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. This indicates that the product may not have been manufactured in accordance with FDA regulations regarding quality and safety controls. The recall was initiated on May 11, 2016, and was classified as Class II by the FDA.

Consumers who have this product should stop using it and contact Profarma Distributors LLC for instructions on how to return the product or obtain a refund. The recall was terminated on January 24, 2017.

The recalled product

Product
VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619
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 # UPE187
  • Exp. 08/17

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 →

Related recalls

Same manufacturer · Profarma Distributors LLC

See all →

Same hazard · cgmp deviation

See all →

Similar recalls