Drug product
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.
D-0370-2022
Product summary
- Event
- Event 89326
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,400 cartons
- Official record key
drug-enforcement:D-0370-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot # 100022393, exp 09/2022
Distribution pattern: Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility