Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD60272_16, EXP: 5/22/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 65162066810, Pedigree: AD73646_13, EXP: 5/30/2014.
PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008060601.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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
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