Drug product
CHORIONIC GONADOTROPIN, Injectable Solution, 200 UNITS/0.1 ML, vial sizes: 4 mL; 5 mL; 6 mL; 7.5 mL ; 9 mL, 10 mL; 12 mL; 15 mL; 20 mL; 28 mL; Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
D-0064-2016
Product summary
- Event
- Event 71806
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 (4mL), 4 (5mL) vials, 9 (6mL) vials, 5 (7.5mL) vials, 4 (10mL) vials, 5 (9mL) vials, 3 (12mL) vials, 2 (15mL) vials, 1 (20mL), 1 (28mL) vials
- Official record key
drug-enforcement:D-0064-2016
Official wording
Reason: Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Code information: 11032014@10, 12082014@3, t01082015@26, t03092015@26, t03132015@13, t03162015@12, t03242015@19, t04092015@21, t05132015@28, t05132015@44, t05202015@22, t05262015@14, t05272015@36, t06172015@27, t06182015@7, t06242015@9, t06292015@11, t07092015@42, t07102015@25, t08012014@1, t09122014@19, t09252014@4, t12242014@2, and t12312014@8.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility