FDA recall F-1129-2016

Product

Andrographis extract 400 mg packaged in a white and orange bottle containing 90 capsules. The bottle has a blue cap and white lettering.

Reason for recall

Undeclared soy lecithin in 5 dietary supplements.

Distribution

Distributed to 499 consignees in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and PR. The one foreign consignee is Natulab in Japan.

Key facts

Status

Terminated

Initiation date

2016-03-18

Report date

2016-05-04

Termination date

2017-07-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomingdale, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1129-2016