Why it was recalled
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Product description
MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
Lot numbers, UPCs & expiration codes
Lot # 1230005, Exp. date 03/30/2024
Where it was sold
Product was distributed nationwide in the USA via Amazon Marketplace.
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-0563-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 8, 2022
- FDA report date
- Feb 23, 2022
- Quantity
- 336 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ABC Sales 1 Inc
Original FDA data
Every field from FDA enforcement report D-0563-2022, exactly as published.
Show all FDA fields
- City
- Monsey
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89558
- Address
- 116 Adar Ct
- Code information
- Lot # 1230005, Exp. date 03/30/2024
- Postal code
- 10952-3361
- Report date
- Feb 23, 2022
- Product type
- Drugs
- Recall number
- D-0563-2022
- Classification
- Class I
- Recalling firm
- ABC Sales 1 Inc
- Product quantity
- 336 cartons
- Termination date
- Mar 4, 2022
- Reason for recall
- Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
- Distribution pattern
- Product was distributed nationwide in the USA via Amazon Marketplace.
- Recall initiation date
- Feb 8, 2022
- Initial firm notification
- Press Release
- Center classification date
- Feb 17, 2022