Drug product
Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, IL 60045. NDC 61703-350-38.
D-0553-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 341 vials
- Official record key
drug-enforcement:D-0553-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: H074437AA
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations