ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Bapti...

FDA Drug Recall #D-0886-2021 — Class II — August 20, 2021

Recall Summary

Recall Number D-0886-2021
Classification Class II — Moderate risk
Date Initiated August 20, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Washington Homeopathic Products, Inc.
Location Berkeley Springs, WV
Product Type Drugs
Quantity 2 1/liter

Product Description

ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Baptista Tinctoria 10X, Phosphorus 10X, Arnica Montana 10X, Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberis Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Alfalfa 3X, Dilution Alcohol 20%, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 225411, Manufactured for Optimal Health Dimensions, Washington Homeopathic Products, Inc. 260 JR Hawvernale Way, Berkeley Springs, WV, 25411,

Reason for Recall

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Distribution Pattern

Distributed Nationwide in the USA

Lot / Code Information

Lot # 25697, no expiry date

Other Recalls from Washington Homeopathic Products, Inc.

Recall # Classification Product Date
D-0618-2024 Class III Complete 30C/200C Homeopathic Kit, Contains: On... May 31, 2024
D-1125-2022 Class II Anthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C,... May 13, 2022
D-1129-2022 Class II Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20... May 13, 2022
D-1140-2022 Class II Tuberculinum Bovinum, Potency: 12C, 30C, 200C, ... May 13, 2022
D-1141-2022 Class II Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid ... May 13, 2022

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.