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Recall Observatory FDA recall evidence

Drug product

Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377

D-1509-2016

June 20, 2016

Class II

Product summary

Firm
W & C dba The Apothecary
Event
Event 74606
Status
Terminated
Classification
Class II
Quantity
840 mL
Official record key
drug-enforcement:D-1509-2016

Official wording

Reason: 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.

Code information: LOT #: 12201604@22

Distribution pattern: MN

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility