D-1089-2019 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
- 4 prescriptions 9 & 10ml injectable
Product Description
HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, 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
Lots: (a) 01112018@19, 04012019@52, 14022019@23, (b) 14012019@36, distributed between 09-01-2018 to 02-20-2019.