The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-916-2013·Announced 2013-08-28

Medicis Recalls CLENZIderm Pore Therapy Due to CLENZIderm Cleanser Mislabeling

Medicis Pharmaceutical Corp is recalling CLENZIderm M.D. Pore Therapy kits because some bottles were incorrectly filled with Daily Foam Cleanser. The recall covers specific lots distributed in the US and internationally.

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. The hazard involves a cGMP deviation resulting in the wrong product being filled in the bottle, which is a labeling/filling error without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Medicis Pharmaceutical Corp is recalling specific lots of the CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit. The recall is limited to the Pore Therapy (Salicylic Acid 2%) component, NDC 62032-110. The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations during production, where CLENZIderm M.D. Daily Foam Cleanser was filled into bottles labeled as CLENZIderm M.D. Pore Therapy.

The recall includes 2,491 kits, expanded on August 29, 2013, to include an additional 907 units. The affected products are Lot #11L1074, NDC 62032-110, and Lot 11J1075, NDC 62032-511, with an expiration date of 10/14. The products were distributed nationwide in the United States, as well as in Great Britain, Mexico, Russia, and The Ukraine.

Consumers should check their CLENZIderm M.D. kits for the specific lot numbers and NDC codes listed above. If the Pore Therapy bottle matches the recalled lot information, consumers should stop using the product and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl…
Manufacturer
Medicis Pharmaceutical Corp
Category
Drug — Topical Acne Treatment
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 (5)

  • Lot #11L1074
  • NDC 62032-110
  • Expanded 8/29/2013 to include Lot 11J1075
  • NDC 62032-511
  • Exp. 10/14.

Distribution

Distributed nationwide across the United States.

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