Drug product
Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
D-1228-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,870 vials
- Official record key
drug-enforcement:D-1228-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: 10122102A2, Exp 3/22/2022; 10252101A2, Exp 3/24/2022; 11092106A2, Exp 4/8/2022; 11232102A1, Exp 5/7/2022; 11162106A1, Exp 5/15/2022; 12032114A1, 02212224A1, Exp 5/22/2022; 12142111A1, 12202109A2, Exp 5/24/2022; 03032244A1, Exp 6/1/2022; 03082209A1, Exp 6/6/2022; 12292116A2, Exp 6/27/2022; 01182204A1, 01262232A1, 01262233A1, Exp 6/30/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility