FDA recall D-1340-2020

Akorn, Inc. · Class III · drug

Product

Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04

Reason for recall

Discoloration: Out of Specification (OOS) result for APHA Color Test.

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2020-06-05
Report date: 2020-06-17
Termination date: 2022-07-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1340-2020