Food, drugs, devices › Washington Homeopathic Products, Inc.
Drug recall: Calcarea Fluorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Produ
FDA enforcement event 84213 is a drug recall by Washington Homeopathic Products, Inc. of Berkeley Springs, WV, initiated 8 Nov 2019 and classified Class II, with 16 product records.
FDA defines Class II as 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. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 4 Jan 2023. Initiation: voluntary: firm initiated. Washington Homeopathic Products, Inc. has 5 enforcement events on this register, with a median of 16 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Washington Homeopathic Products, Inc., Berkeley Springs, WV.
Reason for recall
"CGMP Deviations: products were not manufactured under current good manufacturing practices."
Distribution
"Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0491-2020 | 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. | 489 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0492-2020 | Calcarea Phosphorica 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 64189 7. | 681 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0493-2020 | Calcarea Sulphurica 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 64190 3. | 300 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0494-2020 | Cell Salts Combination 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 64200 9. | 829 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0495-2020 | Ferrum Phosphoricum 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 64198 9. | 462 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0496-2020 | Kali Muriaticum 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 64194 1. | 300 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0497-2020 | Kali Phosphoricum 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 64195 8. | 417 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0498-2020 | Kali Sulphuricum 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 64196 5. | 295 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0499-2020 | Magnesia Phosphorica 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 64197 2. | 487 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0500-2020 | Natrum Muriaticum 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 64191 0. | 366 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0501-2020 | Natrum Phosphoricum 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 64192 7. | 366 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0502-2020 | Natrum Sulphuricum 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 64193 4. | 288 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0503-2020 | 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. | 426 bottles | Class II | Terminated | 27 Nov 2019 |
| D-0504-2020 | Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | 1 bottle | Class II | Terminated | 27 Nov 2019 |
| D-0505-2020 | StellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Calendula Officinalis 1x, Echinacea Purpurea 1x, Plantago Major 1x), packaged in 1000 mL white plastic bottle. | 1 bottle/ | Class II | Terminated | 27 Nov 2019 |
| D-0506-2020 | 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… | a) 1 bottle; b) 11 bottles | Class II | Terminated | 27 Nov 2019 |
Context
Other enforcement events for Washington Homeopathic Products, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 31 May 2024 | Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic | Drug | Class III | 1 |
| 13 May 2022 | Anthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C, 30C, 200C, 11X, 14X, 30X Liquid Pellets, OTC, Washington Homeopathic Pro | Drug | Class II | 17 |
| 20 Aug 2021 | Aconitum nap Fear* 87% Alcohol HPUS: 5X, 7X, 18X, 30X, packaged in 30 mL containers, Aconitum nap Fear* 87% Alcohol HPUS | Drug | Class II | 39 |
| 18 Mar 2021 | Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillo | Drug | Class III | 3 |
All 5 events for Washington Homeopathic Products, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP Deviations: products were not manufactured under current good manufacturing practices."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Jan 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.