The Recall Desk
ModerateFDA (Drugs)·D-1493-2019·Announced 2019-07-31

Pharma-Natural Recalls AbeeMed Cream Due to Manufacturing Violations

Pharma-Natural Inc. is recalling AbeeMed cream 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 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 19,422 jars of AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar. The product was manufactured exclusively for Cas and is identified by UPC 8 50993 00402 4. All lots remaining within their expiry dates 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.

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 check their inventory for this product and stop using it if found.

The recalled product

Product
AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas, P.O. Box 520248, Miami, FL 33152, UPC 8 50993 00402 4.
Manufacturer
Pharma-Natural Inc.
Category
Drug — Topical Cream
Hazard
Affected units
19,422

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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