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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0370-2022 |
Event ID | 89326 |
Brand | METHYLPREDNISOLONE ACETATE |
Generic Name | METHYLPREDNISOLONE ACETATE |
Manufacturer | METHYLPREDNISOLONE ACETATE |
Original Package? | 1 |
Active Substance | METHYLPREDNISOLONE ACETATE |
Drug Route | INTRALESIONAL |
Distribution | Methylprednisolone, TN Norepinephrine BItartrate - MS, OH |
Quantity | 7,400 cartons |
Recall Reason | Lack of Assurance of Sterility |
Drug Classification | Class II |
Drug Code Info | 20220119 |
Product NDC | 16714-089 16714-090 16714-473 |
Recall Initiation Date | 20211231 |
Report Date | 20220119 |
Classification Date | 20220113 |
Address | 400 Interpace Pkwy Parsippany, NJ 07054-1120 United States |
Recalling Firm | Teva Pharmaceuticals USA |
Initial Notification | Letter |
Unique Ingredient Identifier | 43502P7F0P |
Drug Application Number | ANDA040620 |
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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