Class II · Moderate risk
Menastil
cGMP Deviations
StellaLife VEGA Oral Gel Rinse
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
StellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Calendula Officinalis 1x, Echinacea Purpurea 1x, Plantago Major 1x), packaged in 1000 mL white plastic bottle.
Drug: Calendula
- Recalling firm
- Washington Homeopathic Products, Inc.
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0505-2020 · 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 Calendula recalls
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Class II · Moderate risk
ProSirona
cGMP Deviations
Class II · Moderate risk
Neuroquell
cGMP Deviations
Class II · Moderate risk
Neuroquell Plus
cGMP Deviations
Class III · Low risk
Calendula Cream
Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
Other recalls by Washington Homeopathic Products, Inc.
All 2019 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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