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Recall Observatory FDA recall evidence

Drug product

ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3084-07

D-0251-2016

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
Event
Event 72179
Status
Terminated
Classification
Class II
Quantity
12,191 syringes
Official record key
drug-enforcement:D-0251-2016

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 Numbers: 20151706@45 BUD: 12/14/2015; 20151707@16 BUD: 1/13/2016; 20150904@17 BUD: 10/6/2015; 20151703@19 BUD: 9/13/2015; 20153003@7 BUD: 9/26/2015; 20153006@42 BUD: 12/27/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility