FDA recall D-0703-2017

Teva Pharmaceuticals USA · Class III · drug

Product

PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87

Reason for recall

Failed Stability Specifications

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2017-03-28
Report date: 2017-05-17
Termination date: 2017-10-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0703-2017