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
Reported: June 17, 2020 Initiated: June 5, 2020 #D-1340-2020
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.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 17,424 bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn, Inc.. Units affected: 17,424 bottles.
Why was this product recalled? ▼
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 17, 2020. Severity: Low. Recall number: D-1340-2020.
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