Drug product
Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). Compounded by Tri-Coast Pharmacy
D-0294-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 920 vials
- Official record key
drug-enforcement:D-0294-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06152016B (12/12/2016), 07252016C (01/21/2017), 08262016C (02/22/2017), 10192016A (02/28/2017), 10242016B (02/28/2017).
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility