FDA Drug Recalls

Recalls / Class II

Class IID-0256-2019

Product

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

Affected lot / code info
Lot K022216C

Why it was recalled

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Recalling firm

Firm
Silver Star Brands
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
2155 S Oakwood Rd, Oshkosh, Wisconsin 54904-6359

Distribution

Quantity
247 bottles
Distribution pattern
Nationwide USA

Timeline

Recall initiated
2018-10-03
FDA classified
2018-11-19
Posted by FDA
2018-11-14
Terminated
2019-08-25
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0256-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls