7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Dieg...

FDA Drug Recall #D-0880-2018 — Class I — May 17, 2018

Recall Summary

Recall Number D-0880-2018
Classification Class I — Serious risk
Date Initiated May 17, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Shoreside Enterprises Inc.
Location Tampa, FL
Product Type Drugs
Quantity Unknown

Product Description

7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148

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.

Distribution Pattern

Nationwide.

Lot / Code Information

Lot #: RO, Exp. 12/31/2021

Other Recalls from Shoreside Enterprises Inc.

Recall # Classification Product Date
D-0879-2018 Class I POSEIDON Xtreme PLATINUM 4500,1000mg, packaged ... May 17, 2018

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.