FDA recall D-1097-2019

Product

PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 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-1097-2019