Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; BISACODYL EC, Tablet, 5 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD37056_13, EXP: 5/10/2014.
BISACODYL EC, Tablet, 5 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904792760
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: products were stored outside the drug label specifications.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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