Why it was recalled
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Product description
Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02
Lot numbers, UPCs & expiration codes
Lot K022216C
Where it was sold
Nationwide 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-0256-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 3, 2018
- FDA report date
- Nov 14, 2018
- Quantity
- 247 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Silver Star Brands
Original FDA data
Every field from FDA enforcement report D-0256-2019, exactly as published.
Show all FDA fields
- City
- Oshkosh
- State
- WI
- Status
- Terminated
- Country
- United States
- Event ID
- 81228
- Address
- 2155 S Oakwood Rd
- Code information
- Lot K022216C
- Postal code
- 54904-6359
- Report date
- Nov 14, 2018
- Product type
- Drugs
- Recall number
- D-0256-2019
- Classification
- Class II
- Recalling firm
- Silver Star Brands
- Product quantity
- 247 bottles
- Termination date
- Aug 25, 2019
- Reason for recall
- CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Oct 3, 2018
- Initial firm notification
- Press Release
- Center classification date
- Nov 19, 2018