FDA recall D-0639-2022

Product

Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.

Reason for recall

cGmp Deviations

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-02-16

Report date

2022-03-09

Termination date

2023-10-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0639-2022