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Recall Observatory FDA recall evidence

Drug product

Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407

D-0508-2019

January 29, 2019

Class II

Product summary

Firm
US Compounding Inc
Event
Event 82012
Status
Terminated
Classification
Class II
Quantity
1686 syringes
Official record key
drug-enforcement:D-0508-2019

Official wording

Reason: Lack of assurance of sterility.

Code information: Lot: 20181812@2 BUD: 06/16/2019

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility