Drug product
PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
D-1090-2019
Product summary
- Event
- Event 82278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64 prescriptions 5, 10, 6 mL injections
- Official record key
drug-enforcement:D-1090-2019
Official wording
Reason: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Code information: Lot: (a) 18092018@52, 01102018@9, 05102018@36, 08102018@11, 102018@9, 01102018@9, 01102018@9, 03102018@27, 12102018@18, 01102018@9, 12102018@18, 12102018@18, 17102018@15, 12102018@18, 2102018@18, 22102018@31, 30102018@22, 29102018@9,29102018@9 29102018@9, 29102018@9, 12102018@18, 21112018@38, 21112018@38, 21112018@38, 21112018@38, 21112018@38, 21112018@38, 11122018@7, 11122018@7, 28122018@11, 28122018@11, 28122018@11, 03012019@17, 03012019@17, 03012019@17, 08012019@21, 08012019@21,28082018@16 28082018@16, 28082018@16, 14092018@28, 14092018@28, 4092018@28, 14092018@28, 18092018@52, 18092018@52, 8092018@52, 18092018@52, 18092018@52, (b) 29102018@9, 03012019@17,14092018@28, (c) 11012019@64, 11012019@64, 11012019@64, 05022019@27, 5022019@27, 06022019@6, 06022019@6, distributed between 09-01-2018 to 02-20-2019.
Distribution pattern: Dispensed in Oregon
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls