FDA Recalls X-Jow Pain Gel Due to Potential Bacterial Contamination
Shadow Holdings DBA Bocchi Labs is recalling X-Jow Pain Gel because CGMP deviations may have allowed 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 involving potential bacterial contamination, which aligns with the rubric criteria for a Severe rating.
Plain-English summary
Shadow Holdings DBA Bocchi Labs is recalling X-Jow (menthol USP) Pain Gel, 1.25%, in 4 oz. and 8 oz. bottles. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations that may have resulted in the products being contaminated with bacteria.
The affected products were distributed nationwide in the USA by Herb-X Solutions, Inc. The recall covers 12,252 bottles across all lots. The agency has classified this recall as Class II.
Consumers should stop using the product and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.
- Manufacturer
- Shadow Holdings DBA Bocchi Labs
- Category
- Drug — Topical Analgesic
- Hazard
- Affected units
- 12,252
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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