FDA recall D-0174-2016

Pacific Healthcare, Inc dba B&B Pharmacy · Class II · drug

Product

PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Distribution

CA and NJ

Key facts

Status
Terminated
Initiation date
2015-10-07
Report date
2015-11-18
Termination date
2016-04-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bellflower, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0174-2016