PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 17, 2019 Initiated: February 21, 2019 #D-1093-2019

Product Description

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.

Details

Units Affected
13 prescription 5, 6, 9, 10 ml injection
Distribution
Dispensed in Oregon
Location
Corvallis, OR

Frequently Asked Questions

What product was recalled?
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. Recalled by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy. Units affected: 13 prescription 5, 6, 9, 10 ml 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-1093-2019.