Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.
Product description
B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017
Lot numbers, UPCs & expiration codes
lot numbers: F03Q, C02R
Where it was sold
Approximately 30% of all finished products were sold to customers in interstate to include but may not be limited to NY, NJ & CT via UPS. Products are promoted and sold directly to customers at Healthy Life Chemistry's retail store at 13A Lucon Drive in Deer Park, NY, on the company website (www.purityfirst.com), and are available at the health food store, Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com).
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-373-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 31, 2013
- FDA report date
- Dec 25, 2013
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Healthy Life Chemistry Inc dba Purity First
Original FDA data
Every field from FDA enforcement report D-373-2014, exactly as published.
Show all FDA fields
- City
- Deer Park
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 65842
- Address
- 13A Lucon Dr
- Code information
- lot numbers: F03Q, C02R
- Postal code
- 11729-5711
- Report date
- Dec 25, 2013
- Product type
- Drugs
- Recall number
- D-373-2014
- Classification
- Class I
- Recalling firm
- Healthy Life Chemistry Inc dba Purity First
- Product quantity
- unknown
- Termination date
- May 11, 2015
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017
- Distribution pattern
- Approximately 30% of all finished products were sold to customers in interstate to include but may not be limited to NY, NJ & CT via UPS. Products are promoted and sold directly to customers at Healthy Life Chemistry's retail store at 13A Lucon Drive in Deer Park, NY, on the company website (www.purityfirst.com), and are available at the health food store, Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com).
- Recall initiation date
- Jul 31, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 18, 2013