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Recall Observatory FDA recall evidence

Drug product

Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06

D-0286-2016

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
Event
Event 72179
Status
Terminated
Classification
Class II
Quantity
13,843 vials
Official record key
drug-enforcement:D-0286-2016

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: 20150204@7 BUD: 9/29/2015, 20150304@1 BUD: 9/29/2015, 20150604@23 BUD: 10/3/2015, 20150807@50 BUD: 1/4/2016, 20150906@23 BUD: 12/6/2015, 20150906@24 BUD: 12/6/2015, 20152005@42 BUD: 11/16/2015, 20152206@52 BUD: 12/19/2015, 20152406@14 BUD: 12/21/2015, 20152603@26 BUD: 9/22/2015, 20152804@20 BUD: 10/25/2015, 20152904@20 BUD: 10/26/2015, 20152907@8 BUD: 1/25/2016, 20151603@56 BUD: 9/12/2015, 20152406@30 BUD: 12/21/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility