The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0811-2018·Announced 2018-05-23

Milbar Recalls B Prox 10 Anti-blemish Wash Due to Microbial Contamination

Milbar Laboratories is recalling 3,477 bottles of B Prox 10 Anti-blemish Wash due to microbial contamination. Consumers should stop using the product and return it to the point of purchase.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), as the agency's own classification mandates a minimum score of 4.

Plain-English summary

Milbar Laboratories, Inc. is voluntarily recalling 3,477 plastic bottles of B Prox 10 Anti-blemish Wash (Benzoyl peroxide 10%), 200 mL bottles. The product was manufactured by Dermatologic Cosmetic Laboratories in East Haven, CT, and distributed within the United States and Puerto Rico.

The recall was initiated due to microbial contamination of the non-sterile product. The affected lots are # ET507-0 (Expiration 5/27/2019) and # GU894-8 (Expiration 7/20/2010).

Consumers who have purchased this product should stop using it immediately and return it to the point of purchase for a refund. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Manufacturer
Milbar Laboratories, Inc.
Category
Drug — Dermatologic
Hazard
Affected units
3,477

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 (4)

  • Lot: # ET507-0
  • Exp. 5/27/2019
  • GU894-8
  • Exp. 7/20/2010

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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