Pfizer Recalls PROTONIX IV Vials for Subpotent Potency
Pfizer is recalling 582,165 vials of PROTONIX IV (pantoprazole sodium) because the drug failed potency testing at the 6-month stability time point.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of the product is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Pfizer Inc. is recalling 582,165 vials of PROTONIX I.V. (pantoprazole sodium) for Injection, 40 mg per vial. The recall was initiated because the product was found to be out of specification for potency at the 6-month stability time point, meaning the drug may not contain the full labeled amount of the active ingredient.
The affected product is distributed nationwide and includes vials packaged by Pfizer Injectables, NOVAPLUS, and PREMIERPro Rx. Specific lot numbers and expiration dates are listed in the recall documentation, including lots 325449, N97969, N69175, N69177, N95727, M51076, 317364, and N73763.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Healthcare providers and patients should check their inventory for the affected lot numbers and contact Pfizer or their supplier for further instructions on handling the recalled product.
The recalled product
- Product
- PROTONIX (PANTOPRAZOLE SODIUM)
- Brand
- PROTONIX
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 582,165
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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
- b) N73763
Distribution
Distributed nationwide across the United States.
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