FDA recall D-1361-2022

Product

PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24

Reason for recall

Defective Container: Product has incomplete induction seals.

Distribution

Nationwide USA

Key facts

Status

Ongoing

Initiation date

2022-08-01

Report date

2022-08-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1361-2022