FDA-Drug2016-09-28Class II

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

W & C dba The Apothecary
Hazard

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.

Sold states
MN
Affected count
450 mL
Manufactured in
165 19th St S, Suite 102, Sartell, MN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1510-2016

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