FDA recall D-0954-2017

Advanced Pharma Inc. · Class II · drug

Product

Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide with the United States

Key facts

Status
Terminated
Initiation date
2017-06-22
Report date
2017-07-19
Termination date
2017-12-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0954-2017