Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured an...
FDA Drug Recall #D-0879-2016 — Class I — September 23, 2015
Recall Summary
| Recall Number | D-0879-2016 |
| Classification | Class I — Serious risk |
| Date Initiated | September 23, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Lucy's Weight Loss (dba. Waisted With Lucy) |
| Location | Arlington, TX |
| Product Type | Drugs |
| Quantity | Unknown |
Product Description
Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Reason for Recall
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Distribution Pattern
Nationwide
Lot / Code Information
All lots
Other Recalls from Lucy's Weight Loss (dba. Waisted With...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0882-2016 | Class I | Pink Bikini capsules, (all colors and all stren... | Dec 9, 2015 |
| D-0883-2016 | Class I | Shorts on the Beach capsules, (all colors and a... | Dec 9, 2015 |
| D-0880-2016 | Class I | Shorts on The Beach Strong Formula by Pink Biki... | Sep 23, 2015 |
| D-0881-2016 | Class I | Shorts on The Beach Golden Edition by Pink Biki... | Sep 23, 2015 |
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.