PrednisoLONE Oral Solution Recalled for Defective Container Seals
Akorn, Inc. is recalling 14,712 bottles of PrednisoLONE Oral Solution (15 mg/5 mL) due to incomplete induction seals in containers. No illnesses have been reported, but the defect may affect product integrity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of prescription medication with defective container seals. While no illnesses or injuries have been reported, the incomplete seals represent a risk-of-harm to product integrity and medication efficacy.
Plain-English summary
Akorn, Inc. is recalling PrednisoLONE Oral Solution USP (15 mg per 5 mL) in 240 ml bottles due to defective containers with incomplete induction seals. The affected product is distributed under the label of HI-TECH PHARMACAL CO., INC., Amityville, NY, with National Drug Code (NDC) 50383-042-24, Lot # 379804, and expiration date of August 31, 2023.
The recalled product was distributed nationwide in the United States, with 14,712 bottles affected. The defect involves incomplete induction seals on the containers.
No illnesses or injuries have been reported in association with this product.
The recalled product
- Product
- PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
- Manufacturer
- Akorn, Inc
- Hazard
- incomplete-seal
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# 379804
- Exp. 8/31/2023
Distribution
Distributed nationwide across the United States.
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