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Acid Reflux Med Recalled


March 31, 2017

Pfizer Inc issued a voluntary, nationwide recall of 582,165 vials of Protonix® IV (pantoprazole sodium) for injection.

The medication, which contains 40 mg of pantoprazole per vial, is used for the treatment of gastroesophageal reflux disease in individuals with a history of erosive esophagitis and for the treatment of pathological hypersecretory conditions linked to Zollinger-Ellison syndrome or other neoplastic diseases.

The US Food and Drug Administration (FDA) Enforcement Report for the week of March 22, 2017, cites the reason for the recall as “Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.”

The code and packaging information for the recalled product, including national drug codes (NDCs), lot numbers, and expiration dates, is as follows:

  • Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51)
    • Bundles of 10 unit cartons (NDC 0008-0923-55)
      • Lot number 325449, expiration date 12/16  
    • 25 x 40 mg vials per carton (NDC 0008-0923-60)
      • Lot number N97969, expiration date 03/17
      • Lot number N69175, expiration date 03/17
      • Lot number N69177, expiration date 03/17
      • Lot number N95727, expiration date 04/17
  • NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg vials per carton (NDC 0008-0941-03)
    •  Lot number M51076, expiration date 11/16
  • PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01)
    • Bundles of 10 unit cartons (NDC 0008-4001-10)
      • Lot number 317364, expiration date 11/16
    • 25 x 40 mg vials per carton (NDC 0008-4001-25)
      • Lot number N73763, expiration date 03/17

Pfizer initiated this recall on November 22, 2016; it is still in progress.

-Meredith Edwards White

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