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.
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
Lot numbers, UPCs & expiration codes
Lot #: a) 1146, Exp 3/29/20; b) 1138, 1139, Exp 1/31/20; and 1160, Exp 10/10/19
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0002-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 31, 2018
- FDA report date
- Oct 10, 2018
- Quantity
- a) 500 sample packs; b) 672 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BioLyte Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0002-2019, exactly as published.
Show all FDA fields
- City
- Grand Rapids
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 81011
- Address
- 310 Northern Dr. Nw
- Code information
- Lot #: a) 1146, Exp 3/29/20; b) 1138, 1139, Exp 1/31/20; and 1160, Exp 10/10/19
- Postal code
- 49534
- Report date
- Oct 10, 2018
- Product type
- Drugs
- Recall number
- D-0002-2019
- Classification
- Class II
- Recalling firm
- BioLyte Laboratories, LLC
- Product quantity
- a) 500 sample packs; b) 672 bottles
- Termination date
- Aug 31, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 31, 2018
- Initial firm notification
- Telephone
- Center classification date
- Oct 1, 2018