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Recall Observatory FDA recall evidence

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

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility