Class I — High risk. Reasonable probability of serious harm or death.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.
Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Reason Out of Specification for active ingredient
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
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