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Class III · Lower riskRecall completed

Protonix

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: A) a) 325449, Exp 12/16; b) N97969, N69175, N69177, Exp 03/17; N95727, Exp 04/17; B) M51076, Exp 11/16; and C) a) 317364, Exp 11/16; b) N73763, Exp 03/17
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Brand namePROTONIX
Generic namePANTOPRAZOLE SODIUM
Active ingredient(s)PANTOPRAZOLE SODIUM
Distributed by / forWyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany
NDC0008-0923-51
Show the full FDA record
Full product labelPROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in a) bundles of 10 unit cartons (NDC 0008-0923-55) and b) 25 x 40 mg Vials per carton (NDC 0008-0923-60); B) NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg Vials per carton (NDC 0008-0941-03); and C) PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01) in a) bundles of 10 unit cartons (NDC 0008-4001-10) and b) 25 x 40 mg Vials per carton (NDC 0008-4001-25).
Recalling firmPfizer Inc.
DistributionNationwide
Quantity582,165 vials
Recall initiated2016-11-22
Report date2017-03-22
Recall completed2018-06-22
Recall numberD-0516-2017
ClassificationClass III
FDA statusTerminated
Origin on fileNew York NY United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.