Recalls / Class II
Class IID-0002-2019
Product
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
- Brand name
- Neorelief For Muscle Crampling And Restlessness
- Generic name
- Topical Gel For Muscle Cramping And Restlessness
- Active ingredients
- Arnica Montana, Artemisia Cina Pre-flowering Top, Atropa Belladonna Root, Black Cohosh, Causticum, Frangula Californica Bark, Hypericum Perforatum, Jatropha Curcas Seed, Lycopodium Clavatum Spore, Potassium Bromide, Potassium Carbonate, Pseudognaphalium Obtusifolium, Ruta Graveolens Flowering Top, Scutellaria Lateriflora, Strychnos Ignatii Seed, Taraxacum Officinale, Valerian, Veratrum Album Root
- Route
- Topical
- NDC
- 58368-002
- Affected lot / code info
- Lot #: a) 1146, Exp 3/29/20; b) 1138, 1139, Exp 1/31/20; and 1160, Exp 10/10/19
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.
Recalling firm
- Firm
- BioLyte Laboratories, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 310 Northern Dr. Nw, Grand Rapids, Michigan 49534
Distribution
- Quantity
- a) 500 sample packs; b) 672 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-08-31
- FDA classified
- 2018-10-01
- Posted by FDA
- 2018-10-10
- Terminated
- 2020-08-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0002-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.