drugs Class II Updated 2014-08-27

US Compounding Inc recalls ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Singl

Recalled 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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot# 20142104@30 USE BY: 10/18/2014
View official government recall

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