Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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.
Drug: Alcohol
- Recalling firm
- Washington Homeopathic Products, Inc.
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0881-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Alcohol recalls
See all
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Other recalls by Washington Homeopathic Products, Inc.
All 2021 recalls
Class III · Low risk
Complete 30C/200C Homeopathic Kit
Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Class II · Moderate risk
Vaccinotoxinum
cGMP deviations
Class II · Moderate risk
Tuberculinum Bovinum
cGMP deviations
Class II · Moderate risk
Tuberculinum
cGMP deviations
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