Recalls / Class III
Class IIIF-1198-2016
Product
Iowa Select Herbs LLC, Muira Puama (Ptychopetalum ovata), www.iowaselectherbs.com, (a) 1 fl. Oz. (b) 2 fl. Oz. (c) 4 fl. Oz. (d) 1 gallon, Cedar Rapids, IA 52402
- Type
- Food
- Affected lot / code info
- Lot - R11165, Expires - 01/2020;
- Quantity
- (a) 2 bottles, (b) 1 bottle, (c) 18 bottles, (d) 1 bottle
Why it was recalled
Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.
Recalling firm
- Firm
- Iowa Select Herbs LLC
- Notification channel
- Press Release
- Type
- FDA Mandated
- Address
- 2347 Blairs Ferry Rd NE, Suite 2, Cedar Rapids, Iowa 52402-1998
Distribution
- Distribution pattern
- The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.
Timeline
- Recall initiated
- 2015-09-11
- FDA classified
- 2016-05-02
- Posted by FDA
- 2016-05-11
- Terminated
- 2017-02-27
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-1198-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings.