FDA recall D-0008-2017

West-Ward Pharmaceutical · Class II · drug

Product

PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.

Reason for recall

Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.

Distribution

US Nationwide.

Key facts

Status: Terminated
Initiation date: 2016-10-03
Report date: 2016-10-12
Termination date: 2017-12-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0008-2017