FDA recall D-0829-2018

Product

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22

Reason for recall

CGMP Deviations

Distribution

Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2018-04-30

Report date

2018-05-30

Termination date

2019-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0829-2018