Homeopathic drug Proteus recalled for manufacturing quality control deviations
Washington Homeopathic Products is recalling Proteus homeopathic remedy in multiple potencies due to manufacturing process deviations. The firm initiated this voluntary recall in May 2022.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall, which the agency classifies as a risk-of-harm product with potential for serious adverse health consequences. Although no illnesses or injuries have been reported, the regulatory classification and manufacturing process deviations warrant a High severity designation.
Plain-English summary
Washington Homeopathic Products, Inc. is recalling Proteus homeopathic remedy in nine potencies (7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, and 200C) distributed as over-the-counter liquid pellets in glass amber bottles. The recall affects 109 bottles with lot numbers 22747 and 22771.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations in the manufacturing process. The FDA classified this as a Class II recall, indicating the product has potential for serious adverse health consequences.
The affected product was distributed nationwide throughout the United States. The manufacturer voluntarily initiated the recall on May 13, 2022. The FDA terminated the recall on May 25, 2023.
Consumers who have purchased this product should discontinue use. For more information, contact Washington Homeopathic Products, Inc. at 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
The recalled product
- Product
- Proteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, 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
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 (2)
- Lot# 22747
- 22771
Distribution
Distributed nationwide across the United States.
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