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

FDA recall notice · announced June 17, 2020 · Akorn

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot# 365566, 365568
Quantity: 17,424 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1340-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.