The Recall Desk
ModerateFDA (Drugs)·D-1496-2019·Announced 2019-07-31

Pharma-Natural Recalls Army Health Pain Reliever Gel Due to CGMP Violations

Pharma-Natural Inc. is recalling Army Health Pain Reliever Gel with Curcumin because it was manufactured with current good manufacturing practice violations.

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 and involves CGMP deviations without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Pharma-Natural Inc. is recalling 1,508 jars of Army Health Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ. 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 is identified by UPC 8 50993 00461 1. The recall covers all lots remaining within their expiry dates. The product was distributed to consignees in Florida and Texas, who may have further distributed it nationwide in the USA and Puerto Rico.

Consumers should stop using the product and return it to the place of purchase or contact the recalling firm for instructions.

The recalled product

Product
ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured exclusively for: Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00461 1.
Manufacturer
Pharma-Natural Inc.
Category
Drug — Topical Analgesic
Hazard
Affected units
1,508

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

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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.

See all 16 products in this recall →

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