FDA-Drug2017-02-15Class III
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
Dr. Reddy's Laboratories, Inc.
Hazard
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Sold states
US Nationwide
Affected count
5,904 bottles
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0468-2017Don't want to check this manually?
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