Drug product
HCG/Hydroxycobalamin 5,000 IU/5 mg Vial. Compounded by Tri-Coast Pharmacy
D-0262-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,304 vials
- Official record key
drug-enforcement:D-0262-2017
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): 06232016A (12/20/2016), 07192016B (01/15/2017), 08262016A (01/31/2017), 08092016C (01/31/2017), 09192016C (01/31/2017), 11042016C (11/04/2016), 10252016A (02/28/2017)
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility