Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Product description
7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
Lot numbers, UPCs & expiration codes
Lot #: RO, Exp. 12/31/2021
Where it was sold
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-0880-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 17, 2018
- FDA report date
- Jun 6, 2018
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shoreside Enterprises Inc.
Original FDA data
Every field from FDA enforcement report D-0880-2018, exactly as published.
Show all FDA fields
- City
- Tampa
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 80128
- Address
- 6345 Newtown Cir Apt A3 Ste A-3
- Code information
- Lot #: RO, Exp. 12/31/2021
- Postal code
- 33615-3629
- Report date
- Jun 6, 2018
- Product type
- Drugs
- Recall number
- D-0880-2018
- Classification
- Class I
- Recalling firm
- Shoreside Enterprises Inc.
- Product quantity
- Unknown
- Termination date
- Jun 10, 2020
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
- Distribution pattern
- Nationwide.
- Recall initiation date
- May 17, 2018
- Initial firm notification
- Press Release
- Center classification date
- Jun 18, 2018