Papaverine 30 mg / Phentolamine 1 mg / mL recall: Sterility Concern
Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Why was Papaverine 30 mg / Phentolamine 1 mg / mL recalled?
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
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 #: 06201604@15, 19201602@3, 06201604@8
- Product
- Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
- Recalling firm
- W & C dba The Apothecary
- Quantity
- 450 mL
- Distribution
- MN
- Recall date
- September 28, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)