D-1340-2020 Class III Terminated
FDA drug recall D-1340-2020 was initiated by Akorn, Inc. on June 5, 2020 and is designated Class III. Reason for recall: Discoloration: Out of Specification (OOS) result for APHA Color Test. The recall status is terminated (terminated July 28, 2022). Affected quantity: 17,424 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 17, 2020
- Initiation Date
- June 5, 2020
- Termination Date
- July 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,424 bottles
Product Description
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.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot# 365566, 365568