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Recall Observatory FDA recall evidence

Drug product

Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2169-06

D-0282-2016

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
Event
Event 72179
Status
Terminated
Classification
Class II
Quantity
1,386 vials
Official record key
drug-enforcement:D-0282-2016

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: 20151006@46 BUD: 12/7/2015, 20151607@40 BUD: 1/12/2016, 20152005@32 BUD: 11/16/2015, 20152304@28 BUD: 10/20/2015, 20152304@5 BUD: 10/20/2015, 20152606@2 BUD: 12/22/2015, 20152907@16 BUD: 1/23/2016

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility