FDA recall D-1042-2018

Product

Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 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

Defective Container: Tamper Evident foil seal not completely intact.

Distribution

U.S. Nationwide

Key facts

Status

Terminated

Initiation date

2018-07-24

Report date

2018-08-15

Termination date

2022-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morton Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1042-2018