D-0310-2021 Class I Terminated
FDA drug recall D-0310-2021 was initiated by Adams.Secret.co on February 15, 2021 and is designated Class I. Reason for recall: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. The recall status is terminated (terminated April 20, 2022). Affected quantity: 218 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- March 31, 2021
- Initiation Date
- February 15, 2021
- Termination Date
- April 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 218 boxes
Product Description
Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5
Reason for Recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Distribution Pattern
Nationwide in the USA
Code Information
All lots within expiry.