Why it was recalled
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Product description
ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Arsenicum Album 10X, Baptisia Tinctoria 10X, Pulsatilla 10X, Lachesis Mutus 11X, Rhus Toxicodendron 10X, Belladonna 7X, Colchicum Autumnale 5X, Aconitum Napellus 8X, Astragalus Menziesli 8X, Carbo Vegetabilis 8X, Chamomilla 3X, Hydrastis Canadensis 3X, Echinacea Angustifolia 12X, Pulsatilla 11X, Anas Barariae, Hepatis ET 60C, Anas Barariae, Hepatis ET 100C, Anas Barariae, Hepatis ET 200C, Carduus Marianus 6X, Taraxacum Officinale 4X, Berberis Aquifolium 8X, Zingiber Officinal 8X, Allium Sativum 4X, Dilution Alcohol 20%. Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricum Acidum 12X, Phosphoricum Acidum 24X, Rhus Toxicodendron 24X, Secale Cornutum 24X, Secale Cornutum 30X, Sepia 6X, Sepia 24X, Solanum Nigrum 30X, Zincum Valericanicum 8X, Zincum Valerianicum 12X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.
Lot numbers, UPCs & expiration codes
Lot # 25887, Exp 8/17/2026
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0885-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 20, 2021
- FDA report date
- Oct 6, 2021
- Quantity
- 2/1 Liter bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Washington Homeopathic Products, Inc.
Original FDA data
Every field from FDA enforcement report D-0885-2021, exactly as published.
Show all FDA fields
- City
- Berkeley Springs
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 88528
- Address
- 260 J R Hawvermale Way
- Code information
- Lot # 25887, Exp 8/17/2026
- Postal code
- 25411-6957
- Report date
- Oct 6, 2021
- Product type
- Drugs
- Recall number
- D-0885-2021
- Classification
- Class II
- Recalling firm
- Washington Homeopathic Products, Inc.
- Product quantity
- 2/1 Liter bottles
- Termination date
- Jun 21, 2022
- Reason for recall
- Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Arsenicum Album 10X, Baptisia Tinctoria 10X, Pulsatilla 10X, Lachesis Mutus 11X, Rhus Toxicodendron 10X, Belladonna 7X, Colchicum Autumnale 5X, Aconitum Napellus 8X, Astragalus Menziesli 8X, Carbo Vegetabilis 8X, Chamomilla 3X, Hydrastis Canadensis 3X, Echinacea Angustifolia 12X, Pulsatilla 11X, Anas Barariae, Hepatis ET 60C, Anas Barariae, Hepatis ET 100C, Anas Barariae, Hepatis ET 200C, Carduus Marianus 6X, Taraxacum Officinale 4X, Berberis Aquifolium 8X, Zingiber Officinal 8X, Allium Sativum 4X, Dilution Alcohol 20%. Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricum Acidum 12X, Phosphoricum Acidum 24X, Rhus Toxicodendron 24X, Secale Cornutum 24X, Secale Cornutum 30X, Sepia 6X, Sepia 24X, Solanum Nigrum 30X, Zincum Valericanicum 8X, Zincum Valerianicum 12X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Aug 20, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 29, 2021