The Recall Desk
ModerateFDA (Drugs)·D-1500-2019·Announced 2019-07-31

FDA Recalls Dermanak Skin Cream Due to Manufacturing Violations

Pharma-Natural Inc. is recalling Dermanak Skin Fade Cream 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, which typically involves a temporary or medically reversible adverse health consequence. The source text cites manufacturing process violations without reporting specific illnesses or injuries, aligning with a moderate severity rating for a drug recall based on CGMP deviations.

Plain-English summary

Pharma-Natural Inc. is recalling 1,032 jars of Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g) jar, NDC 63788-108-02. The product was manufactured by Pamby Distributors, Inc., in Miami, FL.

The recall was initiated due to current good manufacturing practice (CGMP) deviations. Specifically, the products were manufactured with a lack of process validation, cleaning validation, stability studies, and other CGMP violations. All lots remaining within their expiry date are affected.

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 contact the recalling firm for instructions.

The recalled product

Product
Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g) jar, Manufactured by: Pamby Distributors, Inc., Miami, FL 33126, NDC 63788-108-02.
Manufacturer
Pharma-Natural Inc.
Category
Drug — Topical Dermatology
Hazard
Affected units
1,032

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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