Why it was recalled
Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.
Product description
CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.
Lot numbers, UPCs & expiration codes
Lot #: 072010-22, Exp: 12/2013; Lot #: 072010-23, Exp: 01/2014; Lot #: 072010-25, Exp: 03/2014; Lot #: 072010-26, Exp: 04/2014; Lot #: 072010-27, Exp: 05/2014; Lot #: 072010-29, Exp: 07/2014; Lot #: 072010-30, Exp: 08/2014; Lot #: 072010-31, Exp: 09/2014; Lot #: 072010-33, Exp: 11/2014; Lot #: 072010-34, Exp: 01/2015; Lot #: 072010-36, Exp: 02/2015; Lot #: 072010-39, Exp: 05/2015; Lot #: 072010-43, Exp: 06/2015; and Lot #: 072010-48, Exp: 10/2015.
Where it was sold
U.S. 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-1569-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 20, 2014
- FDA report date
- Sep 17, 2014
- Quantity
- 12,948 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ChiroNutraceutical LLC
Original FDA data
Every field from FDA enforcement report D-1569-2014, exactly as published.
Show all FDA fields
- City
- Chesterfield
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 69076
- Address
- 700 Spirit Of Saint Louis Blvd Ste I
- Code information
- Lot #: 072010-22, Exp: 12/2013; Lot #: 072010-23, Exp: 01/2014; Lot #: 072010-25, Exp: 03/2014; Lot #: 072010-26, Exp: 04/2014; Lot #: 072010-27, Exp: 05/2014; Lot #: 072010-29, Exp: 07/2014; Lot #: 072010-30, Exp: 08/2014; Lot #: 072010-31, Exp: 09/2014; Lot #: 072010-33, Exp: 11/2014; Lot #: 072010-34, Exp: 01/2015; Lot #: 072010-36, Exp: 02/2015; Lot #: 072010-39, Exp: 05/2015; Lot #: 072010-43, Exp: 06/2015; and Lot #: 072010-48, Exp: 10/2015.
- Postal code
- 63005-1025
- Report date
- Sep 17, 2014
- Product type
- Drugs
- Recall number
- D-1569-2014
- Classification
- Class III
- Recalling firm
- ChiroNutraceutical LLC
- Product quantity
- 12,948 Bottles
- Termination date
- Jun 16, 2015
- Reason for recall
- Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Aug 20, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 9, 2014