The Recall Desk
LowFDA (Drugs)·D-1410-2020·Announced 2020-08-05

Allergan Recalls Skin Medica Acne System Kits for Subpotency

Allergan is recalling 8,555 Skin Medica Acne System kits nationwide because the products failed potency tests at 12 and 24 months.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as a situation where use of or exposure to a violative product is not likely to cause adverse health consequences.

Plain-English summary

Allergan PLC is recalling 8,555 kits of the Skin Medica Acne System, which includes a Purifying Foaming Wash, Purifying Toner, and Acne Treatment Lotion. The products were distributed nationwide in the United States.

The recall was initiated because the products failed assay results at the 12 and 24-month timepoints, indicating they were subpotent. The affected lots include 090645A, 090645B, 090645C, 090757A, 093199A, 093199B, 093199C, 093199D, 096375A, 096375B, 097455A, and 097612A, with expiration dates ranging from February 2020 to June 2021.

Consumers should check their products for these specific lot numbers and expiration dates. If the product matches the recalled items, they should stop using it and contact Allergan for a refund or replacement.

The recalled product

Product
Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005
Manufacturer
Allergan PLC
Category
Drug — Topical Acne Treatment
Hazard
Affected units
8,555

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 (18)

  • Lot #: 090645A
  • 090645B
  • Exp. Date 07/31/2020
  • 090645C
  • Exp. Date 08/31/2020
  • Lot #: 090757A
  • Exp. Date 02/29/2020
  • Lot # 093199A
  • 093199B
  • 093199C
  • 093199D
  • Exp. Date 12/31/2020
  • Lot #: 096375A
  • 096375B
  • Exp. Date 06/30/2021
  • Lot #: 097455A
  • 097612A
  • Exp. Date 04/30/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Allergan PLC 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 →

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