The Recall Desk
ModerateFDA (Drugs)·D-1502-2019·Announced 2019-07-31

Pharma-Natural Recalls Lid O Creme Due to Manufacturing Violations

Pharma-Natural Inc. is recalling Lid O Creme topical analgesic cream because it was manufactured with current good manufacturing practice violations, including lack of process 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 cites manufacturing deviations (lack of validation) without reporting specific illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Pharma-Natural Inc. is recalling Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll on bottle, NDC 63788-111-25. The recall involves 310 roll on bottles that were distributed to consignees in Florida and Texas, who may have further distributed the product nationwide in the USA and Puerto Rico. All lots remaining within expiry are affected.

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. These manufacturing deficiencies raise concerns about the product's quality and safety.

Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll on bottle, Manufactured & Distributed by: Pharma Natural, Inc. Hialeah, FL 33016, NDC 63788-111-25.
Manufacturer
Pharma-Natural Inc.
Category
Drug — Topical Analgesic
Hazard
Affected units
310

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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