Drug product
MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.
D-0269-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,736 vials
- Official record key
drug-enforcement:D-0269-2016
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: 20150105@18 BUD: 10/28/2015, 20150805@34 BUD: 11/4/2015, 20152603@12 BUD: 9/21/2015, 20153004@20 BUD: 10/27/2015, 20150805@34 BUD: 11/4/2015, 20152603@12 BUD: 9/21/2015, 20153004@20 BUD: 10/27/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility