Drug product
Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
D-1226-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,208 vials
- Official record key
drug-enforcement:D-1226-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: 10122103A2, Exp 3/22/2022; 11092108A2, Exp 4/30/2022; 11192115A2, Exp 5/7/2022; 12022107A2, Exp 5/22/2022; 12132107A2, Exp 5/24/2022; 01182201A2, Exp 6/30/2022; 02142212A1, Exp 8/13/2022; 03022217A1, Exp 8/29/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility