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FDA (Drug enforcement)Recalled 2018-08-31closedclass ii

BioLyte Laboratories, LLC: 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 Ra

Is my product affected?

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 NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS

Check against the official notice below — it lists the full affected range.

What happened

BioLyte Laboratories, LLC is recalling NeoRelief for Muscle Cramping & Restlessness homeopathic topical gel due to manufacturing deviations. The recalled product was made using active ingredients that were themselves recalled by the manufacturer King Bio Inc. because of water contamination issues. These contamination issues could potentially affect the quality of the finished NeoRelief product.

The recall affects two package types distributed nationwide: 500 sample packs (4 ml) with lot number 1146 and expiration date 3/29/20, and 672 bottles (Net Wt. 2.0 oz / 56.7g) with lot numbers 1138, 1139 (expiration 1/31/20) and 1160 (expiration 10/10/19). The source does not specify what remedy consumers should pursue.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: Nationwide in the USA Quantity: a) 500 sample packs; b) 672 bottles Lot/code info: Lot #: a) 1146, Exp 3/29/20; b) 1138, 1139, Exp 1/31/20; and 1160, Exp 10/10/19

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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