Recalls / Class II
Class IID-0887-2021
Product
ZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberus Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%, WHP Homeopathic Medicine, For Manufacturing Use Only; Manufactured for Optimal Health Dimensions, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 25411,
- Affected lot / code info
- Lot # 25738, no expiry date
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
- 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-0887-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.