Reported Jun 17, 2020 · Terminated
Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC.,…
Akorn, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701
- NDC50383-040-04
- Lot codes and dates
Lot# 365566365568
- Amount recalled
- 17,424 bottles
Where it was sold
- Nationwide
Why it was recalled
Discoloration: Out of Specification (OOS) result for APHA Color Test.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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