Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist...

FDA Drug Recall #D-1125-2018 — Class I — June 26, 2018

Recall Summary

Recall Number D-1125-2018
Classification Class I — Serious risk
Date Initiated June 26, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm World Organix, LLC
Location Las Vegas, NV
Product Type Drugs
Quantity 545 50-count pouches, 27,250 capsules

Product Description

Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist. by World Organix LLC, Las Vegas Nevada UPC# 6 02401 88900 2

Reason for Recall

Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.

Distribution Pattern

Nationwide in the USA.

Lot / Code Information

Lot Code: 112710 Exp 03/2019

Other Recalls from World Organix, LLC

Recall # Classification Product Date
D-1122-2018 Class I Blissful Remedies Red Maeng Da, 100% Mitragyna ... Jun 26, 2018
D-1124-2018 Class I Blissful Remedies Red Maeng Da Liquid Kratom Mi... Jun 26, 2018
D-1123-2018 Class I Blissful Remedies, 4 Hour Chill, Slow Motion Bl... Jun 26, 2018
D-1126-2018 Class I Blissful Remedies Kratom+CBD CBD infused Maeng ... Jun 26, 2018

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

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.