D-1096-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2019
- Initiation Date
- February 21, 2019
- Termination Date
- July 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 prescription 5, 6.5 ml injection
Product Description
PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.5ml, 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.
Distribution Pattern
Dispensed in Oregon
Code Information
Lot: (a) 22102018@31, (b) 09112018@33, distributed between 09-01-2018 to 02-20-2019.