Recalls / Class III
Class IIID-1340-2020
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
- Affected lot / code info
- Lot# 365566, 365568
Why it was recalled
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 17,424 bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-06-05
- FDA classified
- 2020-06-24
- Posted by FDA
- 2020-06-17
- Terminated
- 2022-07-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1340-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.