Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # F51Q. EXP: 07/16 The UPC Codes for Naturect are: 1ct- 893020242013 5ct - 893020242051 10ct - 893020242105 20ct - 893020242204 40ct - 893020242402
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1346-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 19, 2013
- FDA report date
- May 28, 2014
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tendex
Original FDA data
Every field from FDA enforcement report D-1346-2014, exactly as published.
Show all FDA fields
- City
- Beverly Hills
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 66897
- Address
- 311 Robertson Blvd
- Address (line 2)
- Suite 454
- Code information
- Lot # F51Q. EXP: 07/16 The UPC Codes for Naturect are: 1ct- 893020242013 5ct - 893020242051 10ct - 893020242105 20ct - 893020242204 40ct - 893020242402
- Postal code
- 90211
- Report date
- May 28, 2014
- Product type
- Drugs
- Recall number
- D-1346-2014
- Classification
- Class I
- Recalling firm
- Tendex
- Product quantity
- unknown
- Termination date
- Sep 18, 2014
- Reason for recall
- Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Nov 19, 2013
- Initial firm notification
- Press Release
- Center classification date
- May 21, 2014