26 FDA recalls mention Pantoprazole. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pantoprazole.
Reason Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Reason Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Reason CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Reason CGMP Deviations: Discoloration
Reason Lack of sterility assurance
Reason Discoloration
Reason cGMP deviations: Temperature abuse
Reason CGMP deviations: tablets cracking
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Impurity/Degradation Specifications
Reason CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Reason CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Reason Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Reason Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Reason Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Reason Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Reason Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Reason Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of…
Reason Labeling: Label Mixup: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as one of the following drugs: HYOSCYAMINE SULFATE SL…
Reason Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 40 mg may be potentially mislabeled as SENNOSIDES, Tablet, 8.6 mg, NDC 60258095001, Pedigree…
Reason Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102…
Reason Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as DRONEDARONE HCL, Tablet, 400 mg, NDC 00024414260…
Reason Labeling: Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabel as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301…
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