Recalls / Class II
Class IID-0881-2021
Product
ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Crataegus Oxyacantha 10X, Baryta Carbonica 10X, Digitalis Purpurea 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only, Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.
- Affected lot / code info
- Lot # 25740, Exp 8/17/2026
Why it was recalled
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
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
- 1 1/Liter bottle
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-08-20
- FDA classified
- 2021-09-29
- Posted by FDA
- 2021-10-06
- Terminated
- 2022-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0881-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.