FDA-Drug2017-05-17Class III
Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
Sun Pharmaceutical Industries, Inc.
Hazard
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Sold states
Nationwide in the USA and Puerto Rico
Affected count
60 bottles
Manufactured in
270 Prospect Plains Rd, N/A, Cranbury, NJ, United States
Products
Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0699-2017Don't want to check this manually?
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