Home / Recalls / W & C dba The Apothecary / D-1510-2016

D-1510-2016 Class II Terminated

Recalled by W & C dba The Apothecary — Sartell, MN

Recall Details

Product Type
Drugs
Report Date
September 28, 2016
Initiation Date
June 20, 2016
Termination Date
April 19, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
450 mL

Product Description

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

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.

Distribution Pattern

MN

Code Information

LOT #: 06201604@15, 19201602@3, 06201604@8

Other recalls by W & C dba The Apothecary

  • D-1508-2016 Class II — Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A CO (June 20, 2016)
  • D-1512-2016 Class II — Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A (June 20, 2016)
  • D-1511-2016 Class II — Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VI (June 20, 2016)
  • D-1509-2016 Class II — Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A CO (June 20, 2016)