Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: glyBURIDE, Tablet, 1.25 mg may have potentially been mislabeled as one of the following drugs: CYPROHEPTADINE HCL, Tablet, 4 mg, NDC 60258085001, Pedigree: W003676, EXP: 6/25/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: AD21790_1, EXP: 5/1/2014.
glyBURIDE, Tablet, 1.25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093834201.
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 CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Reason Labeling: Label Mixup: glyBURIDE, Tablet, 2.5 mg may have potentially been mislabeled as one of the following drugs: sulfaSALAzine, Tablet, 500 mg…
Reason Labeling: Label Mixup: glyBURIDE MICRONIZED, Tablet, 3 mg may have potentially been mislabeled as the following drug: DIGOXIN, Tablet, 0.125 mg, NDC…
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