Pharma-Natural Recalls Army Health Pain Reliever Roll-On for CGMP Violations
Pharma-Natural Inc. is recalling Army Health Pain Reliever Roll-On bottles due to manufacturing process violations. The product was distributed in Florida and Texas.
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 CGMP deviations (lack of validation/studies) without reported illnesses or injuries, fitting the criteria for moderate severity.
Plain-English summary
Pharma-Natural Inc. is recalling 4,981 bottles of ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML). The product was manufactured exclusively for Crossover Telecom, LLC. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically a lack of process validation, cleaning validation, and stability studies.
The affected product was distributed to consignees in Florida and Texas, who may have further distributed the product nationwide in the USA and Puerto Rico. The recall includes all lots remaining within their expiry dates.
Consumers who have this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle, Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00408 6.
- Manufacturer
- Pharma-Natural Inc.
- Category
- Drug — Topical Analgesic
- Affected units
- 4,981
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 remaining within expiry.
Distribution
Part of a larger recall action
This product is one of 16 recalled by Pharma-Natural 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.
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