The Recall Desk
SevereFDA (Drugs)·D-0860-2018·Announced 2018-06-20

Acne Shave Shave Cream Recalled for Potential Bacterial Contamination

Shadow Holdings DBA Bocchi Labs is recalling Acne Shave Shave Cream due to CGMP deviations that may allow bacterial contamination.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving potential contamination or significant injury risks are categorized as Severe (Score 4), as they are not Class I but involve more than minor labeling issues.

Plain-English summary

Shadow Holdings DBA Bocchi Labs is recalling Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tubes. The recall involves 8,208 tubes distributed nationwide in the USA by United Exchange Corp. All lots are affected.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. These deviations mean the products may be contaminated with bacteria.

Consumers who have this product should stop using it and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6.
Manufacturer
Shadow Holdings DBA Bocchi Labs
Category
Drug — Topical OTC
Hazard
Affected units
8,208

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)

  • All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Shadow Holdings DBA Bocchi Labs 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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Same manufacturer · Shadow Holdings DBA Bocchi Labs

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Same hazard · bacterial contamination

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