FDA recall D-0156-2018

Product

Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2017-12-07

Report date

2018-01-17

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0156-2018