Class I — High risk. Reasonable probability of serious harm or death.
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count blister: UPC 736211123916.
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: finished products were manufactured with poor quality water.
Reason Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients…
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