The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1495-2019·Announced 2019-07-31

FDA Recalls Oliver's Harvest CBD+Lidocaine Cream for Manufacturing Violations

Pharma-Natural Inc. is recalling Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief Cream due to current good manufacturing practice violations, including lack of process and cleaning validation.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 due to CGMP violations (lack of validation and stability studies) without reported illnesses or injuries, fitting the 'voluntary precautionary recalls' or 'low-risk contamination' criteria for a Moderate severity score.

Plain-English summary

Pharma-Natural Inc. is recalling 1,000 bottles of Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump. The product is distributed by Coast to Coast Natural, Inc., in Wellington, FL, and carries NDC 63766-119-04. The recall covers all lots remaining within their expiration dates.

The recall was initiated because the products were manufactured with current good manufacturing practice (CGMP) violations. Specifically, the source text notes a lack of process validation, cleaning validation, and stability studies. The FDA has classified this recall as Class II.

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 distributor or manufacturer for instructions on return or disposal.

The recalled product

Product
Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63766-119-04.
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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