Drug product
medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02
D-0563-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 148 syringes
- Official record key
drug-enforcement:D-0563-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: DN0428
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations