Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 ...

FDA Drug Recall #D-1144-2016 — Class I — December 15, 2015

Recall Summary

Recall Number D-1144-2016
Classification Class I — Serious risk
Date Initiated December 15, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bee Extremely Amazed LLC
Location Jewett, OH
Product Type Drugs
Quantity 581 bottles

Product Description

Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando FL 32801 (407)930-4043

Reason for Recall

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.

Distribution Pattern

Nationwide

Lot / Code Information

All lots

Other Recalls from Bee Extremely Amazed LLC

Recall # Classification Product Date
D-1149-2016 Class I XCEL Capsules, 300 mg, 60-count bottles, Manufa... Dec 15, 2015
D-1145-2016 Class I Prime Capsules, 500mg, 60-count bottles, Distri... Dec 15, 2015
D-1150-2016 Class I XCEL ADVANCED Capsules, 350mg, 60-count bottles... Dec 15, 2015
D-1140-2016 Class I EVOLVE BEE POLLEN Capsules, 250mg, 60-count bot... Dec 15, 2015
D-1142-2016 Class I Jenesis Capsules, 350 mg, 60-count bottles, Ma... Dec 15, 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.