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Recall Observatory FDA recall evidence

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

August 31, 2018

Class II

Product summary

Firm
BioLyte Laboratories, LLC
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

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations