FDA-Drug2020-06-17Class III

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

Akorn, Inc.
Hazard

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

Sold states
Distributed Nationwide in the USA
Affected count
17,424 bottles
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
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

Official notice

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

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