Drug product
HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy.
D-0261-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,884 vials
- Official record key
drug-enforcement:D-0261-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot codes: 06222016D, 06062016C, 07192016C07062016A, 08182016B, 08112016A, 08012016A, 09282016A, 09122016D, 10182016C, 11042016B, 11012016F; Exp. 11/16
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility