Drug product
Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
D-1220-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 243 vials
- Official record key
drug-enforcement:D-1220-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: a) 10272107A1, Exp 4/25/2022; 12072130A1, Exp 6/5/2022; b) 01032230A1, Exp 7/2/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility