FDA recall D-0175-2016
Pacific Healthcare, Inc dba B&B Pharmacy · Class II · drug
Product
PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, 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-0175-2016