Papa/phen/prost recall: Sterility Concern
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057…
Why was Papa/phen/prost recalled?
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
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 #: 09192016@41,09192016@69, Exp 11/04/2016
- Product
- PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057…
- Recalling firm
- Fallon Wellness Pharmacy, L.L.C.
- Quantity
- 10 vials
- Distribution
- NY
- Recall date
- December 14, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)