Chirothin Dietary Supplement Recalled for Unapproved Human Chorionic Gonadotropin
ChiroNutraceutical LLC is recalling Chirothin dietary supplement bottles because the product contains unapproved human chorionic gonadotropin (hCG) and was marketed without an approved NDA or ANDA.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
ChiroNutraceutical LLC is recalling 12,948 bottles of Chirothin Dietary Supplement, 2 Fl Oz (60 ml), OTC. The product was distributed nationwide in the United States. The recall involves specific lots with expiration dates ranging from December 2013 to October 2015.
The FDA is recalling this product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains unapproved human chorionic gonadotropin (hCG). The agency has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who purchased Chirothin Dietary Supplement should check their lot numbers and expiration dates against the list provided in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.
- Manufacturer
- ChiroNutraceutical LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 12,948
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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