Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30

Recall Number: D-1314-2020

Firm: Aurobindo Pharma USA Inc.

Classification: Class III

Status: Terminated

Report Date: 20200624

Initiation Date: 20200526

Termination Date: 20230110

Failed Impurities/ Degradation Specifications

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30