FDA-Drug2020-06-24Class III

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

Aurobindo Pharma USA Inc.
Hazard

Failed Impurities/ Degradation Specifications

Sold states
U.S.A. Nationwide
Affected count
13322 bottles
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1314-2020

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