FDA recall D-0824-2018

Product

Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01

Reason for recall

CGMP Deviations

Distribution

Product was distributed throughout the United States, including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2018-04-24

Report date

2018-05-30

Termination date

2019-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0824-2018