D-1105-2019 Class II Terminated
FDA drug recall D-1105-2019 was initiated by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy on February 21, 2019 and is designated Class II. Reason for recall: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. The recall status is terminated (terminated July 23, 2020). Affected quantity: 2 prescriptions, 5ml injection.
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 prescriptions, 5ml injection
Product Description
PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, 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:26112018@68, 13122018@12, distributed between 09-01-2018 to 02-20-2019.