D-0002-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 10, 2018
- Initiation Date
- August 31, 2018
- Termination Date
- August 31, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 500 sample packs; b) 672 bottles
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: a) 1146, Exp 3/29/20; b) 1138, 1139, Exp 1/31/20; and 1160, Exp 10/10/19