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.
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 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.
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