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METHYLPREDNISOLONE ACETATE Recall D-0370-2022

Description: MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.

METHYLPREDNISOLONE ACETATE Recall D-0370-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0370-2022
Event ID89326
BrandMETHYLPREDNISOLONE ACETATE
Generic NameMETHYLPREDNISOLONE ACETATE
ManufacturerMETHYLPREDNISOLONE ACETATE
Original Package?1
Active SubstanceMETHYLPREDNISOLONE ACETATE
Drug RouteINTRALESIONAL
DistributionMethylprednisolone, TN Norepinephrine BItartrate - MS, OH
Quantity7,400 cartons
Recall ReasonLack of Assurance of Sterility
Drug ClassificationClass II
Drug Code Info20220119
Product NDC16714-089 16714-090 16714-473
Recall Initiation Date20211231
Report Date20220119
Classification Date20220113
Address400 Interpace Pkwy
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA
Initial Notification Letter
Unique Ingredient Identifier43502P7F0P
Drug Application NumberANDA040620
Structured Product Labeling (SPL ID)177dfcf0-e2ff-48df-a8df-8e5c18481739
Structured Product Labeling (SPL Set ID)be407d75-c347-4adb-b165-5bd23a0a0fe5
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