Drug product
Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0201-99
D-0247-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,984 bottles
- Official record key
drug-enforcement:D-0247-2016
Official wording
Reason: Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Code information: Lot Numbers: 20150506@6 BUD: 11/28/2015; 20150805@40 BUD: 10/31/2015; 20151206@7 BUD: 12/5/2015; 20151704@21 BUD: 10/10/2015; 20152003@43 BUD: 9/12/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility