Recalls / Class III
Class IIID-0516-2017
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).
- Brand name
- Protonix
- Generic name
- Pantoprazole Sodium
- Active ingredient
- Pantoprazole Sodium
- Route
- Intravenous
- NDCs
- 0008-0923, 0008-4001
- FDA application
- NDA020988
- Affected lot / code info
- 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
Why it was recalled
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 582,165 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-22
- FDA classified
- 2017-03-10
- Posted by FDA
- 2017-03-22
- Terminated
- 2018-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0516-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.