The Recall Desk
ModerateFDA (Drugs)·D-1499-2019·Announced 2019-07-31

Pharma-Natural Recalls LidoAID Gel Due to Manufacturing Violations

Pharma-Natural Inc. is recalling LidoAID topical analgesic gel because it was manufactured with current good manufacturing practice violations, including a lack of process and cleaning validation.

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 the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Pharma-Natural Inc. is recalling 2,000 bottles of LidoAID (Lidocaine HCL 4%) portable pain relieving topical analgesic gel. The product is distributed by Diabetic Supply of Suncoast, Inc., dba Advocate Diabetes, and is identified by NDC 63788-114-04. The recall covers all lots remaining within their expiry dates.

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, and stability studies, along with other CGMP violations. These manufacturing deficiencies raise concerns about the product's quality and safety.

The affected product was distributed to consignees in Florida and Texas, who may have further distributed it nationwide in the United States and in Puerto Rico. Consumers who have this product should stop using it and contact the distributor or manufacturer for instructions on how to return or dispose of the product.

The recalled product

Product
LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by: Diabetic Supply of Suncoast, Inc., dba Advocate Diabetes, PO Box 2102, Vega Alta, PR 00692, NDC 63788-114-04.
Manufacturer
Pharma-Natural Inc.
Category
Drug — Topical Analgesic
Hazard
Affected units
2,000

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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