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🏥 FDA: Annora Pharma Private Limited — Class III

healthcareneutralSource: FDA
75%Confidence
0Views
FDASource
2026-04-09Date

Summary

Annora Pharma's Class III recall for Pitavastatin tablets due to incorrect tablet mixing poses a low health risk but reveals serious packaging errors at an Indian manufacturer supplying Northstar Rx. This highlights quality control vulnerabilities in generic drug manufacturing, potentially leading to stricter FDA oversight of foreign production sites.

Actionable: Review the quality audit history of Annora Pharma to gauge systemic risks in their manufacturing processes.

AI Confidence: 75%

Data Points

firmAnnora Pharma Private Limited
classificationClass III
statusOngoing
distributionTN
productPitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Phar

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