Homeopathic Drug Diphtherinum Recalled for Manufacturing Practice Deviations
Washington Homeopathic Products is recalling Diphtherinum homeopathic remedy (potencies 14C, 30C, 200C) distributed nationwide due to manufacturing practice deviations (cGMP violations). Affected lots: 20332, 20333.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing process deviation (cGMP violation) rather than a specific health threat. Voluntary recall initiated by the manufacturer indicates lower immediate risk.
Plain-English summary
Washington Homeopathic Products, Inc. is recalling Diphtherinum, a prescription homeopathic remedy available in 14C, 30C, and 200C potencies as liquid pellets. The recall covers lots 20332 and 20333, which were distributed nationwide.
The recall was initiated due to deviations from Current Good Manufacturing Practice (cGMP) standards. This was a voluntary recall initiated by the manufacturer on May 13, 2022. The recall was terminated on May 25, 2023.
No illnesses or injuries have been reported in connection with this recall. Consumers and healthcare providers who have received this product should verify the lot numbers and contact their healthcare provider or the manufacturer with questions.
The recalled product
- Product
- Diphtherinum, Potency: 14C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411,
- Manufacturer
- Washington Homeopathic Products, Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 7
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 # 20332
- 20333
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.
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