Recalls / Class I
Class ID-1125-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Affected lot / code info
- Lot Code: 112710 Exp 03/2019
Why it was recalled
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.
Recalling firm
- Firm
- World Organix, LLC
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 6149 S. Rainbow Blvd #5, N/A, Las Vegas, Nevada 89118
Distribution
- Quantity
- 545 50-count pouches, 27,250 capsules
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2018-06-26
- FDA classified
- 2018-08-23
- Posted by FDA
- 2018-08-15
- Terminated
- 2024-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1125-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.