GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS…
Reason CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: glyBURIDE, Tablet, 2.5 mg may have potentially been mislabeled as one of the following drugs: sulfaSALAzine, Tablet, 500 mg, NDC 59762500001, Pedigree: AD46265_13, EXP: 5/15/2014; ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: W003687, EXP: 6/26/2014; RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: AD21790_22, EXP: 5/1/2014; carBAMazepine ER, Tablet, 100 m
glyBURIDE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093834301.
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, 1.25 mg may have potentially been mislabeled as one of the following drugs: CYPROHEPTADINE HCL, Tablet, 4…
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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