Protonix Injection, Powder, For Solution
FDA Recall NDC 0008-4001
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Protonix (NDC 0008-4001). A significant event, classified as Class III, was initiated on Nov 22, 2016 by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The reported reason for this action was: "Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Nov 22, 2016
Mar 22, 2017
582,165 vials
Recall Profile & Regulatory Data
Event ID
75871
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 22, 2018
Product Description
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).
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
0008-0923-51Product
0008-0923-60Product
0008-0923-55Product
0008-4001-01Product
0008-4001-10Product
0008-4001-25Product
00008-0941-01Product
0008-0941-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
