FDA recall D-0130-2020

Product

Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08

Reason for recall

Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14

Distribution

Nationwide USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-09-23

Report date

2019-10-16

Termination date

2022-09-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morton Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0130-2020