Papaverine-phentolamine-pge1 22-0.8 Mg-8 Mcg/ml* recall
PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW…
Why was Papaverine-phentolamine-pge1 22-0.8 Mg-8 Mcg/ml* recalled?
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Quantity
- 64 prescriptions 5, 10, 6 mL injections
- Distribution
- Dispensed in Oregon
- Recall date
- April 17, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)