Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1136-2022·Announced 2022-06-22

Pyrogenium Homeopathic Remedy Recalled for Manufacturing Process Violations

Washington Homeopathic Products is recalling Pyrogenium homeopathic remedies in multiple potencies due to current Good Manufacturing Practice (cGMP) deviations. The firm initiated this voluntary recall affecting 6,782 bottles distributed nationwide.

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: This is an FDA Class II recall initiated voluntarily by the firm for cGMP deviations. No illnesses, injuries, or confirmed product defects were reported. The hazard is based on manufacturing process non-compliance, qualifying as a precautionary recall per the rubric criterion for voluntary recalls.

Plain-English summary

Washington Homeopathic Products, Inc. is recalling Pyrogenium homeopathic remedies available in multiple potencies (15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C) sold as over-the-counter liquid pellets. The recall affects 6,782 glass amber bottles.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations in the manufacturing process. These deviations indicate the products were not manufactured under conditions required by FDA regulations.

The product was distributed nationwide throughout the United States. Consumers who have purchased Pyrogenium from the affected lots (Lot# 17931-1, 26684, 17528-1, 30755, 30406, 30515, 29079, 29221, 26953, 23757) should discontinue use and contact the manufacturer or their healthcare provider if they have questions. Washington Homeopathic Products, Inc. is located at 260 J R Hawvermale Way, Berkeley Springs, WV 25411. This voluntary recall was initiated on May 13, 2022, and was terminated on May 25, 2023.

The recalled product

Product: Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Manufacturer: Washington Homeopathic Products, Inc.
Category: Drug — Homeopathic
Hazard: cGMP-violation
Affected units: 6,782

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 (10)

Lot# 17931-1
26684
17528-1
30755
30406
30515
29079
29221
26953
23757

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Washington Homeopathic Products, 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 17 products in this recall →

Same manufacturer · Washington Homeopathic Products, Inc.

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