FDA recall F-2144-2019

Jivan Shakti Inc. · Class III · food

Product

Plastic Bottles labeled with: "Ancient Youth Secret - Since 500 B.C., DR. NARAM'S RASAYANA D TABLET, Calcium Supplement with Vitamin D*, Dietary Supplement, 60 Tablets, FOR EXPORT ONLY, Imported & Distributed by: Jivan Shakti INC, 933 South Street, Peekskill, NY 10566, Manufactured by: Reve Pharma, Plot No-78, STICE, Sinnar, Nashik-422 112, Maharashtra, India, Mfr. Lic. No.: NK/AYU/004/08, Batch No: RST-010, Mfr. Date: 05/2018, Exp. Date: 04/2021, Dose: 1 Tab AM, 1 Tab PM"

Reason for recall

Product label declares Vitamin D3 at 200 IU per serving. FDA sample analysis revealed no Vitamin D in product.

Distribution

Product was distributed in: AZ, CA, CT, FL, GA, IL, IN, MA, MD, MI, MN, NC, NJ, NY, OH, PA, TN, TX, VA, WA

Key facts

Status
Terminated
Initiation date
2019-08-28
Report date
2019-09-18
Termination date
2021-01-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Peekskill, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-2144-2019