Drug product
CHORIONIC GONADOTROPIN, Injectable Solution, 5000 UNITS/0.1 mL, vial sizes: 5 mL; 6 mL; 8 mL; 10 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
D-0065-2016
Product summary
- Event
- Event 71806
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 (5mL) vials, 2 (6mL) vials, 8 (8mL) vials, 2 (10mL) vials
- Official record key
drug-enforcement:D-0065-2016
Official wording
Reason: Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Code information: t12292014@35, t12192014@15, t12162014@29, t10232014@24, t09162014@29, t09032014@6, t07252014@16, t07142015@6, t07022015@8, t06152015@32, t05272015@33, t04282015@11, t04162015@34, t04092015@8, t04022015@30, t02262015@24, t02032015@21, and t01232015@10
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility