FDA Recall D-0785-2022
Pink Toyz · Chatsworth, CA
Class I — life-threatening Terminated 855 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6.
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall record
- Recall number
D-0785-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide in the USA via walmart.com online marketplace
- Recall initiated
- 2022-03-29
- Classified by FDA Center
- 2022-04-25
- FDA published
- 2022-04-27
- Terminated
- 2024-07-31
- Recalling firm
- Pink Toyz
- Firm location
- Chatsworth, CA