Washington Homeopathic Recalls Calcarea Fluorica 6X Tablets for CGMP Deviations
Washington Homeopathic Products, Inc. is recalling 489 bottles of Calcarea Fluorica 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 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, which typically involves a temporary or medically reversible adverse health consequence. The source text cites CGMP deviations without reporting specific illnesses or injuries, aligning with a moderate severity rating for a voluntary precautionary recall.
Plain-English summary
Washington Homeopathic Products, Inc. is recalling 489 bottles of Calcarea Fluorica 6X Tablets, 300-count, 30g. The product is manufactured in India exclusively for Washington Homeopathic Products, Inc., located in Berkeley Springs, WV. The specific lot number is BR18C279, and the barcode is 7 40640 64188 0.
The recall was initiated because the products were not manufactured under current good manufacturing practices (CGMP). This classification indicates a deviation from the required standards for drug production.
The product was distributed nationwide throughout the United States, Canada, and Saudi Arabia. Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Calcarea Fluorica 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 64188 0.
- Manufacturer
- Washington Homeopathic Products, Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 489
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 #: BR18C279
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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