Drug & medication recalls

Akorn, Inc. recalls Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville…

Recall date
June 5, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1340-2020
FDA classification
Class III
Brand / firm
Akorn, Inc.
Sold / distributed
Distributed Nationwide in the USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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

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