Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin recall: Sterility Concern
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab…
Why was Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin recalled?
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
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 #: 03052018@54
- Product
- Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab…
- Recalling firm
- Vitalab Pharmacy, Inc
- Quantity
- N/A
- Distribution
- The recalled product was distributed to patients throughout the United States.
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)