Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry...
FDA Drug Recall #D-371-2014 — Class I — August 5, 2013
Recall Summary
| Recall Number | D-371-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | August 5, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bethel Nutritional Consulting, Inc |
| Location | New York, NY |
| Product Type | Drugs |
| Quantity | 9,121 bottles |
Product Description
Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spirulina) capsules, 400 mg, 30-count bottle, Distributed by: Bethel, Inc., Tel: (212) 568-5330.
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Distribution Pattern
Nationwide, Puerto Rico, and internet sales
Lot / Code Information
Lot 10032011, Exp 10/14
Other Recalls from Bethel Nutritional Consulting, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1207-2015 | Class I | SLIM-K, 30 Capsules, barcode 160126417509, Dist... | Dec 19, 2014 |
| D-0424-2015 | Class II | B-Lipo, 30 Capsules, Manufactured by KM DALI, K... | Dec 19, 2014 |
| D-372-2014 | Class I | Bethel Advance (bitter orange, mulberry leaf, c... | Aug 5, 2013 |
| D-921-2013 | Class I | Bethel 30 capsules, packaged in 30 count bottle... | Jun 11, 2013 |
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.