D-1098-2019 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
- 25 prescriptions 10, 9, ml injectable
Product Description
PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, 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) 26092018@22, 26092018@22, 09102018@47, 15102018@33, 15102018@33, 09102018@47, 15102018@33, 09102018@47, 29112018@4, 10122018@14, 29112018@4, 29112018@4, 19122018@20, 21122018@29, 21122018@29, 27122018@20, (b) 16012019@59, 18012019@17, 21012019@49, 21012019@49, 22012019@24, 22012019@24, distributed between 09-01-2018 to 02-20-2019.