FDA recall D-1035-2020

Par Pharmaceutical Inc. · Class III · drug

Product

PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31

Reason for recall

Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg

Distribution

U.S.A. Nationwide

Key facts

Status
Terminated
Initiation date
2020-03-04
Report date
2020-03-25
Termination date
2021-04-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chestnut Ridge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1035-2020