Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho E...

FDA Drug Recall #D-1329-2014 — Class I — July 19, 2013

Recall Summary

Recall Number D-1329-2014
Classification Class I — Serious risk
Date Initiated July 19, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Herbal Give Care Llc
Location Grand Prairie, TX
Product Type Drugs
Quantity 1053 bottles of 30 capsules each

Product Description

Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060

Reason for Recall

Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.

Distribution Pattern

Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.

Lot / Code Information

All lots

Other Recalls from Herbal Give Care Llc

Recall # Classification Product Date
D-1331-2014 Class I Esbelder Siloutte Suplemento Alimenticio, 30 c... Jul 19, 2013
D-1330-2014 Class I Esbelin Siloutte Te, Suplemento Alimenticio, he... Jul 19, 2013
D-1333-2014 Class I Esbelder Fem Mezcla con L-Carnitina Suplemento ... Jul 19, 2013
D-1332-2014 Class I Esbelder Man Herbal Blend With L-Carnitine Diet... Jul 19, 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.