PlainRecalls
FDA Drug Low Class III Terminated

Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30

Reported: June 24, 2020 Initiated: May 26, 2020 #D-1315-2020

Product Description

Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30

Reason for Recall

Failed Impurities/ Degradation Specifications

Details

Recalling Firm
Aurobindo Pharma USA Inc.
Units Affected
7547 bottles
Distribution
U.S.A. Nationwide
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30. Recalled by Aurobindo Pharma USA Inc.. Units affected: 7547 bottles.
Why was this product recalled?
Failed Impurities/ Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on June 24, 2020. Severity: Low. Recall number: D-1315-2020.