Product Safety Recalls

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METHYLPREDNISOLONE Recall D-0752-2022

Description: Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06

METHYLPREDNISOLONE Recall D-0752-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0752-2022
Event ID89923
BrandMETHYLPREDNISOLONE
Generic NameMETHYLPREDNISOLONE
ManufacturerMETHYLPREDNISOLONE
Original Package?1
Active SubstanceMETHYLPREDNISOLONE
Drug RouteORAL
DistributionNationwide in the USA and Puerto Rico
Quantity19,222 Bottles (100-count)
Recall ReasonSubpotent
Drug ClassificationClass III
Drug Code Info20220413
Product NDC59746-001 59746-002 59746-003
Product NUIN0000175576 N0000175450
Drug UPC0359746003142 0359746001032 0359746002046
Pharma Class (EPC)Corticosteroid [EPC]
Recall Initiation Date20220401
Report Date20220413
Classification Date20220406
Address207 Kiley Dr
Salisbury, MD 21801-2249
United States
Recalling FirmJubilant Cadista Pharmaceuticals, Inc.
Initial Notification Letter
Unique Ingredient IdentifierX4W7ZR7023
Drug Application NumberANDA040189
Structured Product Labeling (SPL ID)f7ee0424-d881-4ae1-98be-e8863a8f78fe
Structured Product Labeling (SPL Set ID)7bf4d3d3-3f8a-4e20-9194-061658efca61
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