Drug product
Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02
D-0248-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,333 vials
- Official record key
drug-enforcement:D-0248-2016
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: 20150107@23 BUD: 12/28/2015; 20151305@43 BUD: 11/9/2015; 20151307@18 BUD: 1/9/2016; 20152204@33 BUD: 10/19/2015; 20152606@1 BUD: 12/22/2015; 20153003@34 BUD: 9/26/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility