Akorn Recalls Prednisolone Sodium Phosphate Oral Solution Due to Discoloration
Akorn, Inc. is recalling specific lots of Prednisolone Sodium Phosphate Oral Solution because the product failed a color test.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as unlikely to cause adverse health consequences. The issue is a cosmetic defect (discoloration) with no reported injuries.
Plain-English summary
Akorn, Inc. is recalling 17,424 bottles of Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL. The affected product is identified by NDC 50383-040-04 and includes Lot numbers 365566 and 365568. The recall was initiated because the product produced an Out of Specification (OOS) result for the APHA Color Test, indicating discoloration.
The affected medication was distributed nationwide in the USA. The source text does not report any illnesses or injuries associated with this recall.
Consumers should check their medication for the specific NDC and lot numbers listed above. If the product matches the recalled items, they should contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- 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
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 17,424
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 365566
- 365568
Distribution
Distributed nationwide across the United States.
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