PlainRecalls
FDA Drug Moderate Class II Terminated

PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Reported: April 17, 2019 Initiated: February 21, 2019 #D-1095-2019

Product Description

PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, 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.

Details

Units Affected
2 prescription 5ml injection
Distribution
Dispensed in Oregon
Location
Corvallis, OR

Frequently Asked Questions

What product was recalled?
PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330. Recalled by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy. Units affected: 2 prescription 5ml injection.
Why was this product recalled?
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 17, 2019. Severity: Moderate. Recall number: D-1095-2019.