Drug product
HCG 11,000 IU Vial. Compounded by Tri-Coast Pharmacy
D-0263-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,229 vials
- Official record key
drug-enforcement:D-0263-2017
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): 06152016A (12/12/2016), 07252016D (01/21/2017), 07112016C (01/07/2017), 08312016B (02/27/2017), 08262016B (02/22/2017), 08092016D (02/05/2017), 08052016A (02/01/2017), 09282016B (02/28/2017), 09222016D (02/28/2017), 09072016A (02/28/2017), 10252016J (02/28/2017), 10182016D (02/28/2017), 10102016H (02/28/2017), 11042016A (02/28/2017), 11012016E (02/28/2017)
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility