Reported Mar 22, 2017 · Terminated
PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only,…
Pfizer Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pfizer Inc. · 235 East 42nd Street · New York, NY · 10017-5703
Is this the product you have?
7 of 7 products
| # | Product as published |
|---|---|
| 1 | Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in |
| 2 | bundles of 10 unit cartons (NDC 0008-0923-55) and |
| 3 | 25 x 40 mg Vials per carton (NDC 0008-0923-60) |
| 4 | NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg Vials per carton (NDC 0008-0941-03); and |
| 5 | PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01) in |
| 6 | bundles of 10 unit cartons (NDC 0008-4001-10) and |
| 7 | 25 x 40 mg Vials per carton (NDC 0008-4001-25). |
- Lot codes and dates
Lot #: A) a) 325449Exp 12/16b) N97969N69175N69177Exp 03/17N95727Exp 04/17B) M51076Exp 11/16and C) a) 317364Exp 11/16b) N73763Exp 03/17
- Amount recalled
- 582,165 vials
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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