FDA recall D-1548-2014

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

Reason for recall

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-05-16

Report date

2014-08-27

Termination date

2014-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Conway, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1548-2014