REGULATORY INTELLIGENCE·Recall
Aurobindo Pharma USA Recalls Olanzapine Tablets Over Impurity and Degradation Failures
Aurobindo Pharma USA Inc. initiated a Class III nationwide recall (D-1315-2020) for 7,547 bottles of Olanzapine Tablets, USP 7.5 mg, manufactured by Aurolife Pharma LLC. The action, terminated January 10, 2023, stemmed from failed impurities/degradation specifications. This highlights critical quality control vulnerabilities for procurement and regulatory teams, necessitating rigorous supplier oversight, especially for generic pharmaceuticals distributed through partners like Prasco Laboratories.
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