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Recall Observatory FDA recall evidence

Drug product

Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01

D-0287-2016

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
Event
Event 72179
Status
Terminated
Classification
Class II
Quantity
33,778 vials
Official record key
drug-enforcement:D-0287-2016

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: 20150608@19 BUD: 2/2/2016, 20150807@35 BUD: 1/4/2016, 20152104@12 BUD: 10/1//2015, 20150105@2 BUD: 10/28/2015, 20150605@36 BUD: 11/2/2015, 20150607@26 BUD: 1/2/2016, 20150904@32 BUD: 10/6/2015, 20150906@35 BUD: 12/6/2015, 20151506@45 BUD: 12/12/2015, 20151603@43 BUD: 9/12/2015, 20152204@15 BUD: 10/19/2015, 20152506@35 BUD: 12/22/2015, 20152907@1 BUD: 1/25/2016

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility