Class II · Moderate risk
Oxygen
CGMP Deviations
NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.
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
NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02
Affected NDC
58368-0002-02
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Neorelief for Muscle Crampling and Restlessness topical gel for muscle cramping and restlessness NDC 58368-0002 |
CAUSTICUM 4 [hp_X]/g; JATROPHA CURCAS SEED 8 [hp_X]/g; FRANGULA CALIFORNICA BARK 4 [hp_X]/g; RUTA GRAVEOLENS FLOWERING TOP 4 [hp_X]/g; ARNICA MONTANA 4 [hp_X]/g; ATROPA BELLADONNA ROOT 4 [hp_X]/g; BLACK COHOSH 4 [hp_X]/g; ARTEMISIA CINA PRE-FLOWERING TOP 8 [hp_X]/g; PSEUDOGNAPHALIUM OBTUSIFOLIUM 4 [hp_X]/g; HYPERICUM PERFORATUM 4 [hp_X]/g; STRYCHNOS IGNATII SEED 4 [hp_X]/g; POTASSIUM BROMIDE 4 [hp_X]/g; POTASSIUM CARBONATE 4 [hp_X]/g; LYCOPODIUM CLAVATUM SPORE 4 [hp_X]/g; SCUTELLARIA LATERIFLORA 4 [hp_X]/g; TARAXACUM OFFICINALE 4 [hp_X]/g; VALERIAN 8 [hp_X]/g; VERATRUM ALBUM ROOT 8 [hp_X]/g | Gel Topical |
BioLyte Laboratories, LLC | OTC |
- Recalling firm
- BioLyte Laboratories, LLC
- NDC code
- 58368-002-02
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0002-2019 · 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.
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All cgmp deviation recalls
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