FDA recall D-0701-2017

Product

Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), 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-0701-2017