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Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Lack of Assurance of Sterility
Product is mislabeled.
Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Undeclared Fish allergen (parvalbumin).
Undeclared milk allergen
CGMP Deviations