Multi-event March 2021 FDA Recall Drug by Washington Homeopathic Products, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Washington Homeopathic Products, Inc. on March 18, 2021 for the product Drug. The FDA reported the reason for recall as an error occurred where the product was manufactured with potassium chloride instead of potassium phosphate.. The product was distributed in Product was distributed to MD, CO & TX only and the recall is currently terminated.

Reported Recall Events

D-0323-2021 TERMINATED D-0322-2021 TERMINATED D-0321-2021 TERMINATED

Recall Number: D-0323-2021

Reason for Recall
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Initiated
03-18-2021
Reported
04-14-2021
Quantity
300 liters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87547
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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 to MD, CO & TX only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-13-2021
Product Description About Product Description
Full technical description of the product.
LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411

Batch or Lot Expiration Information

Lot# 28506

Recall Number: D-0322-2021

Reason for Recall
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Initiated
03-18-2021
Reported
04-14-2021
Quantity
114 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87547
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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 to MD, CO & TX only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-13-2021
Product Description About Product Description
Full technical description of the product.
Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411

Batch or Lot Expiration Information

Lot# 24844, 25500, 26310

Recall Number: D-0321-2021

Reason for Recall
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Initiated
03-18-2021
Reported
04-14-2021
Quantity
1,909 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87547
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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 to MD, CO & TX only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-13-2021
Product Description About Product Description
Full technical description of the product.
Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42

Batch or Lot Expiration Information

Lot# 27479, exp. date 11/2022