FDA recall D-1314-2020

Product

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

Reason for recall

Failed Impurities/ Degradation Specifications

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2020-05-26

Report date

2020-06-24

Termination date

2023-01-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

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