The Recall Desk
ModerateFDA (Drugs)·D-0096-2021·Announced 2020-11-25

Milbar Recalls Salicylic Acid Shampoo Due to GMP Deviations

Milbar Laboratories is recalling Salicylic Acid Shampoo 3% due to Good Manufacturing Practice deviations. The product was distributed in the US and internationally.

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

Plain-English summary

Milbar Laboratories, Inc. is voluntarily recalling 198.8 kg of Salicylic Acid Shampoo 3%, Bulk Product, manufactured for 360 Therapeutics. The recall was initiated on October 9, 2020, and is classified as Class II by the FDA. The reason for the recall is Good Manufacturing Practice (GMP) deviations.

The affected product is identified by Lot # HV349. The product was distributed throughout the United States, including Puerto Rico, and internationally. The recall status is currently Terminated, with a termination date of January 4, 2023.

Consumers who have this product should stop using it and contact Milbar Laboratories for further instructions. The recall was initiated by the firm and notified via letter.

The recalled product

Product
Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics
Manufacturer
Milbar Laboratories, Inc.
Category
Drug — Topical Shampoo
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 (1)

  • Lot #: HV349

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 14 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 14 products in this recall →

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