ChemLifeIntel/Companies/Ongoing

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REGULATORY INTELLIGENCE·Recall

Guardian Drug Co. Inc. Faces Nationwide Class II Recall for HyVee Antacid Due to Metallic Contamination

Guardian Drug Co. Inc. initiated a nationwide Class II recall for HyVee Ultra Strength Antacid (Calcium Carbonate 1000 mg) due to metallic particle contamination. This marks a recurring quality issue for the firm, demanding immediate supply chain re-evaluation and heightened due diligence from procurement and regulatory teams to mitigate risk and ensure patient safety.

90-Day Activity

Ongoing

PSPriya Subramaniam· Intelligence Analyst

8d ago▲ Trending signal

REGULATORY INTELLIGENCE·Warning Letter

FDC Limited Faces Class II Recall for Defective Timolol Maleate Ophthalmic Solution in US Market

FDC Limited's voluntary Class II recall of 362,544 bottles of Timolol Maleate Ophthalmic Solution due to defective containers signals critical manufacturing control deficiencies. This event impacts US supply chains, particularly distributor Rising Pharma Holdings, Inc., and necessitates immediate procurement risk assessment for ophthalmic drug portfolios. Businesses must evaluate supplier quality systems to mitigate disruption and ensure patient safety.

90-Day Activity

Ongoing

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2024-08-21