FDA recall D-0699-2017

Product

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.

Reason for recall

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2017-03-22

Report date

2017-05-17

Termination date

2018-07-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0699-2017