The Recall Desk
ModerateFDA (Drugs)·D-1503-2019·Announced 2019-07-31

Pharma-Natural Recalls Dayma Pain Gel for Manufacturing Violations

Pharma-Natural Inc. is recalling 1,000 jars of Dayma SUPER FORTE XL10 Pain Relieving Topical Analgesic Gel due to 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 1,000 jars of Dayma SUPER FORTE XL10 Pain Relieving Topical Analgesic Gel. The product is a 4-ounce jar containing Camphor 0.5%, Menthol 2%, and Methyl Salicylate 2%. The recall is being conducted by the U.S. Food and Drug Administration under recall number D-1503-2019.

The recall is due to current good manufacturing practice (CGMP) deviations. Specifically, the products were manufactured with a lack of process validation, cleaning validation, and stability studies, along with other CGMP violations. The agency has classified this recall as Class II.

The affected product was distributed to consignees in Florida and Texas, who may have further distributed it nationwide in the USA and Puerto Rico. All lots remaining within their expiry dates are subject to this recall. Consumers should stop using the product and follow instructions from the recalling firm or the FDA.

The recalled product

Product
Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.
Manufacturer
Pharma-Natural Inc.
Category
Drug — Topical Analgesic
Hazard
Affected units
1,000

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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