Drug product
Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02
D-0272-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,218 vials
- Official record key
drug-enforcement:D-0272-2016
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 Code: 20150604@4 BUD: 10/3/2015, 20152205@1 BUD: 11/18/2015, 20152303@3 BUD: 9/19/2015, 20150604@1 BUD: 10/3/2015, 20151304@27 BUD: 9/19/2015, 20151506@19 BUD: 12/12/2015, 20151506@27R BUD: 11/28/2015, 20151603@2 BUD: 9/12/2015, 20152004@13 BUD: 10/17/2015, 20152206@13 BUD: 12/19/2015, 20152906@7 BUD: 12/26/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility