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Recall Observatory FDA recall evidence

Drug product

Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2171-02

D-0270-2016

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
Event
Event 72179
Status
Terminated
Classification
Class II
Quantity
5,919 vials
Official record key
drug-enforcement:D-0270-2016

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: 20151008@2 BUD: 2/6/2016, 20151307@2 BUD: 1/9/2016, 20153107@27 BUD: 1/27/2016

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility