FDAFDA · Food and drugs·Recall number D-0516-2017
PROTONIX 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).
Published March 22, 2017 · Recall initiated: November 22, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PROTONIX
- Manufacturer
- Pfizer Inc.
- Distributor
- Nationwide
- Lot
- Lot #: 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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