Product Safety Recalls

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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

Mandated?Voluntary: Firm initiated
Recall NumberD-1361-2022
Event ID90676
Original Package?1
Active SubstancePREDNISOLONE
Drug RouteORAL
DistributionNationwide USA
Quantity14,712 bottles
Recall ReasonDefective Container: Product has incomplete induction seals.
Drug ClassificationClass II
Drug Code Info20220824
Product NDC50383-042
Product NUIN0000175576 N0000175450
Pharma Class (EPC)Corticosteroid [EPC]
Recall Initiation Date20220801
Report Date20220824
Classification Date20220819
Address5605 Centerpoint Ct Ste B
Gurnee, IL 60031-5278
United States
Recalling FirmAkorn, Inc
Initial Notification Letter
Unique Ingredient Identifier9PHQ9Y1OLM
Drug Application NumberANDA040401
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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