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NP Thyroid 60

TRACKED

CASHSN
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
14
Manufacturers monitored
38
Intelligence briefs
3
Active regulatory actions
₹2,800 Cr
Est. India export value

INTELLIGENCE

Showing 2 of 2 briefs for NP Thyroid 60
REGULATORY INTELLIGENCE·Warning Letter

FDA Class I Recall: Acella Pharmaceuticals' NP Thyroid 15 Subpotency Raises Critical Supply Chain Concerns

Acella Pharmaceuticals, LLC faced an FDA Class I recall for subpotent NP Thyroid 15 tablets, containing less levothyroxine than labeled. This event, terminated in December 2022, underscores critical quality control and supply chain risks for procurement and regulatory teams in the US pharmaceutical market, demanding enhanced supplier due diligence.

90-Day Activity
PSPriya Subramaniam· Intelligence Analyst
2020-10-28 Warning Letter
REGULATORY INTELLIGENCE·Recall

Acella Pharmaceuticals' NP Thyroid 60 Class I Recall: Superpotency Risks and Supply Chain Implications

Acella Pharmaceuticals, LLC initiated a Class I recall of 29,304 bottles of NP Thyroid 60 (Levothyroxine, Liothyronine) due to superpotency, posing significant patient risk and supply chain disruption. This event, terminated in January 2022, underscores critical quality control vulnerabilities for manufacturers of thyroid hormone replacement therapies, demanding rigorous supplier vetting and robust analytical testing protocols from procurement and regulatory teams.

90-Day Activity
PSPriya Subramaniam· Intelligence Analyst
2020-06-10 Recall