Why it was recalled
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Product description
DHEA 25 mg, bulk capsules
Lot numbers, UPCs & expiration codes
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lots and expiration dates: Lot # 140714 Exp. Date 08/17, Lot # 310914 Exp. Date 10/17, Lot # 560914 Exp. Date 10/17, Lot # 271214 Exp. Date 12/17, Lot # 070115 Exp. Date 01/18, Lot # 460315 Exp. Date 04/18, Lot # 080615 Exp. Date 08/18
Where it was sold
Products distributed to Florida, Nevada and the Dominican Republic
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-0994-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 13, 2015
- FDA report date
- Jan 4, 2017
- Quantity
- 1,444,900 capsules
- Recall type
- FDA Mandated
- Recalling firm
- Sunset Natural Products Inc.
Original FDA data
Every field from FDA enforcement report F-0994-2017, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 74054
- Address
- 7345 SW 45th St
- Code information
- As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lots and expiration dates: Lot # 140714 Exp. Date 08/17, Lot # 310914 Exp. Date 10/17, Lot # 560914 Exp. Date 10/17, Lot # 271214 Exp. Date 12/17, Lot # 070115 Exp. Date 01/18, Lot # 460315 Exp. Date 04/18, Lot # 080615 Exp. Date 08/18
- Postal code
- 33155-4509
- Report date
- Jan 4, 2017
- Product type
- Food
- Recall number
- F-0994-2017
- Classification
- Class II
- Recalling firm
- Sunset Natural Products Inc.
- Product quantity
- 1,444,900 capsules
- Termination date
- Apr 10, 2017
- Reason for recall
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Voluntary / mandated
- FDA Mandated
- Product description
- DHEA 25 mg, bulk capsules
- Distribution pattern
- Products distributed to Florida, Nevada and the Dominican Republic
- Recall initiation date
- Oct 13, 2015
- Initial firm notification
- Letter
- Center classification date
- Dec 28, 2016