PlainRecalls
FDA Drug Moderate Class II Terminated

Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377

Reported: September 28, 2016 Initiated: June 20, 2016 #D-1511-2016

Product Description

Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377

Reason for Recall

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.

Details

Recalling Firm
W & C dba The Apothecary
Units Affected
600 mL
Distribution
MN
Location
Sartell, MN

Frequently Asked Questions

What product was recalled?
Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377. Recalled by W & C dba The Apothecary. Units affected: 600 mL.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 28, 2016. Severity: Moderate. Recall number: D-1511-2016.