Drug product
ALPROSTADIL/PROCAINE, Injectable Solution, 40 MCG/0.1%/ML, 10 mL and 20 mL vials, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
D-0057-2016
Product summary
- Event
- Event 71806
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 vials
- Official record key
drug-enforcement:D-0057-2016
Official wording
Reason: Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Code information: t01212015@26, t01292015@12, t02062015@28, t02092015@14, t02182015@37, t03112015@21, t03302015@3, t05182015@26, t06012015@9, t06042015@31, t06102015@29, t06222015@36, t07062015@4, t07312014@30, t08052014@19, t10082014@18, t10132014@8, t10142014@11, t10232014@23, t11072014@7, t11112014@24, t11182014@13, t12152014@15, and t12162014@7.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility