Multi-event November 2019 FDA Recall Drug by Washington Homeopathic Products, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Washington Homeopathic Products, Inc. on November 8, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0503-2020 TERMINATED D-0505-2020 TERMINATED D-0495-2020 TERMINATED D-0498-2020 TERMINATED D-0502-2020 TERMINATED D-0500-2020 TERMINATED D-0499-2020 TERMINATED D-0497-2020 TERMINATED D-0491-2020 TERMINATED D-0506-2020 TERMINATED D-0494-2020 TERMINATED D-0504-2020 TERMINATED D-0493-2020 TERMINATED D-0496-2020 TERMINATED D-0492-2020 TERMINATED D-0501-2020 TERMINATED

Recall Number: D-0503-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
426 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : BR18B278

Recall Number: D-0505-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
1 bottle/

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# 29488

Recall Number: D-0495-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
462 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# BR18C281

Recall Number: D-0498-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
295 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : BR18B276

Recall Number: D-0502-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
288 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : BR18C280

Recall Number: D-0500-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
366 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : BR18B274

Recall Number: D-0499-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
487 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : BR18C283

Recall Number: D-0497-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
417 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : BR18B272

Recall Number: D-0491-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
489 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : BR18C279

Recall Number: D-0506-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
a) 1 bottle; b) 11 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : 28557

Recall Number: D-0494-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
829 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : BC18C142 and BC18G056

Recall Number: D-0504-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

Batch or Lot Expiration Information

Lot# : 101471, Exp 08/01/2020

Recall Number: D-0493-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
300 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : BR18B277

Recall Number: D-0496-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
300 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : BR18B275

Recall Number: D-0492-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
681 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : BR18C282 and BR18K166

Recall Number: D-0501-2020

Reason for Recall
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Initiated
11-08-2019
Reported
11-27-2019
Quantity
366 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84213
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Washington Homeopathic Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : BR18B273