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
D-1340-2020
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 85801
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,424 bottles
- Official record key
drug-enforcement:D-1340-2020
Official wording
Reason: Discoloration: Out of Specification (OOS) result for APHA Color Test.
Code information: Lot# 365566, 365568
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification