Recalls / Class III
Class IIID-0322-2021
Product
Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411
- Affected lot / code info
- Lot # 24844, 25500, 26310
Why it was recalled
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Recalling firm
- Firm
- Washington Homeopathic Products, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 260 J R Hawvermale Way, N/A, Berkeley Springs, West Virginia 25411-6957
Distribution
- Quantity
- 114 bottles
- Distribution pattern
- Product was distributed to MD, CO & TX only
Timeline
- Recall initiated
- 2021-03-18
- FDA classified
- 2021-04-05
- Posted by FDA
- 2021-04-14
- Terminated
- 2021-05-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0322-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.