Drug 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
D-0002-2019
Product summary
- Event
- Event 81011
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 500 sample packs; b) 672 bottles
- Official record key
drug-enforcement:D-0002-2019
Official wording
Reason: 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.
Code information: Lot #: a) 1146, Exp 3/29/20; b) 1138, 1139, Exp 1/31/20; and 1160, Exp 10/10/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations