# FDA recall D-0516-2017

> **Pfizer Inc.** · Class III · drug recall initiated 2016-11-22.

## Product

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).

## Reason for recall

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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0516-2017
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-11-22
- **Report date:** 2017-03-22
- **Termination date:** 2018-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0516-2017

## Citation

> AI Analytics. FDA recall D-0516-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0516-2017. Source: US FDA. Licensed CC0.

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