FDA recall D-1023-2017
SCA Pharmaceuticals · Class II · drug
Product
PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40
Reason for recall
Lack of Assurance of Sterility; product has the potential to leak.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2017-07-14
- Report date
- 2017-08-02
- 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-1023-2017