CLASS II Drug recall · Reported 27 Nov 2019 · FDA Enforcement Report
R2103, Active Ingredients: Berberis Aquifolium 3x recalled
Washington Homeopathic Products is recalling R2103, Active Ingredients: Berberis Aquifolium 3x, distributed nationwide in the US. The recall was initiated on 8 Nov 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0506-2020
- FDA event ID
- 84213
- Recalling firm
- Washington Homeopathic Products, Berkeley Springs, WV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Nov 2019
- FDA classified
- 18 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 8 Nov 2019 | Recall initiated by company | |
| 18 Nov 2019 | Classified by FDA | +10 days |
| 27 Nov 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Product as listed by the FDA
R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilution alcohol, packaged in a) 470 mL bottle and b) 1000 mL bottle; Manufactured for Wisconsin Pharmacal Company, By: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
Where it was distributed
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Questions about this recall
Why was it recalled?
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Which lots are affected?
Lot #: 28557
Where was it sold?
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
15 other products · FDA event 84213This product is part of a recall event; the main page for the event is Calcarea Sulphurica recalled by Washington Homeopathic.