The Recall Desk
ModerateFDA (Drugs)·D-0833-2018·Announced 2018-05-30

Milbar Recalls Subpotent Zoma Shampoo Bottles

Milbar Laboratories is recalling 1,348 bottles of Zoma Shampoo because the product was found to be subpotent.

What this means for you

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 III, which indicates a low risk of adverse health consequences, and the issue is a subpotent product without reported injuries.

Plain-English summary

Milbar Laboratories, Inc. is voluntarily recalling 1,348 bottles of Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. The recall was initiated because the product was found to be subpotent, meaning it did not contain the full amount of the active ingredient required by the label.

The affected product includes Lot # HT659-6 with an expiration date of 08/11/2019 and Lot LT168-7 with an expiration date of 11/10/2019. The shampoo was distributed to physicians and through internet sales throughout the United States, as well as in Hong Kong, Panama, the UK, China, Jordan, Qatar, Kuwait, and Central America.

Consumers who have purchased this product should stop using it and contact Milbar Laboratories, Inc. for further instructions or a refund. The recall was initiated on May 4, 2018, and was terminated on March 18, 2019.

The recalled product

Product
Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Manufacturer
Milbar Laboratories, Inc.
Category
Drug — Topical Dermatologic
Hazard
Affected units
1,348

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 (3)

  • Lot # HT659-6
  • expiration date 08/11/2019 LT168-7
  • expiration date 11/10/2019

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Milbar Laboratories, Inc. 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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