Drug product
NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466
D-1346-2014
Product summary
- Firm
- Tendex
- Event
- Event 66897
- Status
- Terminated
- Classification
- Class I
- Quantity
- unknown
- Official record key
drug-enforcement:D-1346-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
Code information: Lot # F51Q. EXP: 07/16 The UPC Codes for Naturect are: 1ct- 893020242013 5ct - 893020242051 10ct - 893020242105 20ct - 893020242204 40ct - 893020242402
Distribution pattern: Nationwide.
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.