Washington Homeopathic Products Recalls Silicea 6X Tablets for CGMP Deviations
Washington Homeopathic Products, Inc. is recalling 426 bottles of Silicea 6X Tablets because they were not manufactured under current good manufacturing practices.
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 3/5 (High).
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: The recall is classified as FDA Class II, which involves a risk of temporary or medically reversible adverse health consequences. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).
Plain-English summary
Washington Homeopathic Products, Inc. is recalling 426 bottles of Silicea 6X Tablets, 300-count bottle, 30g. The product was manufactured in India exclusively for Washington Homeopathic Products, Inc., located in Berkeley Springs, WV. The specific lot number is BR18B278.
The recall was initiated because the products were not manufactured under current good manufacturing practices (CGMP). This classification indicates a potential risk of harm, though the source text does not specify the exact nature of the manufacturing deviation or report any specific illnesses or injuries.
The product was distributed nationwide throughout the United States, Canada, and Saudi Arabia. Consumers should stop using the recalled product and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Silicea 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64199 6.
- Manufacturer
- Washington Homeopathic Products, Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 426
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)
- Lot #: BR18B278
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 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.
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