Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling:Label Mixup; PROMETHAZINE HCL, Tablet, 25 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002574, EXP: 6/3/2014.
PROMETHAZINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162052110
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: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason cGMP deviations: Temperature abuse
Reason CGMP Deviations
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
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