PlainRecalls
FDA Drug Moderate Class II Terminated

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 .

Reported: April 17, 2019 Initiated: February 21, 2019 #D-1097-2019

Product Description

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.

Details

Units Affected
3 prescription 5, 10 ml injection
Distribution
Dispensed in Oregon
Location
Corvallis, OR

Frequently Asked Questions

What product was recalled?
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 .. Recalled by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy. Units affected: 3 prescription 5, 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-1097-2019.