The Recall Desk
ModerateFDA (Drugs)·D-1501-2019·Announced 2019-07-31

Lido E.R. Lidocaine Cream Recalled for Manufacturing Violations

Pharma-Natural Inc. is recalling Lido E.R. Lidocaine Cream due to current good manufacturing practice violations, including 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 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 1,070 jars of Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, NDC 63788-115-04. The product was distributed by Diabetic Supply of Suncoast, Inc. to consignees in Florida and Texas, who may have further distributed the product nationwide in the USA and Puerto Rico. The recall includes 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.

Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the product.

The recalled product

Product
Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, Distributed by Diabetic Supply of Suncoast, Inc., P.O. Box 2102, Vega Alta, PR 00692, NDC 63788-115-04.
Manufacturer
Pharma-Natural Inc.
Category
Drug — Topical Analgesic
Hazard
Affected units
1,070

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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