FDA recall D-1093-2019

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy · Class II · drug

Product

PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Reason for recall

Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.

Distribution

Dispensed in Oregon

Key facts

Status: Terminated
Initiation date: 2019-02-21
Report date: 2019-04-17
Termination date: 2020-07-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Corvallis, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1093-2019