PREDNISOLONE Recall D-1361-2022
Description: 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
PREDNISOLONE Recall D-1361-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1361-2022 |
| Event ID | 90676 |
| Brand | PREDNISOLONE |
| Generic Name | PREDNISOLONE |
| Manufacturer | PREDNISOLONE |
| Original Package? | 1 |
| Active Substance | PREDNISOLONE |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 14,712 bottles |
| Recall Reason | Defective Container: Product has incomplete induction seals. |
| Drug Classification | Class II |
| Drug Code Info | 20220824 |
| Product NDC | 50383-042 |
| Product NUI | N0000175576 N0000175450 |
| Pharma Class (EPC) | Corticosteroid [EPC] |
| Recall Initiation Date | 20220801 |
| Report Date | 20220824 |
| Classification Date | 20220819 |
| Address | 5605 Centerpoint Ct Ste B Gurnee, IL 60031-5278 United States |
| Recalling Firm | Akorn, Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9PHQ9Y1OLM |
| Drug Application Number | ANDA040401 |
| Structured Product Labeling (SPL ID) | b5de81e0-d706-4e32-8eef-63611d0f7fa3 |
| Structured Product Labeling (SPL Set ID) | 6b201232-4a52-487c-b963-a98539469e5d |
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