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Recall Observatory FDA recall evidence

Drug product

ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588

D-1548-2014

May 16, 2014

Class II

Product summary

Firm
US Compounding Inc
Event
Event 68336
Status
Terminated
Classification
Class II
Quantity
762 Syringes
Official record key
drug-enforcement:D-1548-2014

Official wording

Reason: Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL.

Code information: Lot# 20142104@30 USE BY: 10/18/2014

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled