Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling:Label Mixup; RAMIPRIL, Capsule, 2.5 mg, Rx only may be potentially mislabeled as PROPAFENONE HCL, Tablet, 150 mg, NDC 00591058201, Pedigree: AD54549_13, EXP: 5/20/2014; CALCIUM POLYCARBOPHIL, Tablet, 625 mg, NDC 00536430611, Pedigree: AD73592_11, EXP: 5/31/2014.
RAMIPRIL, Capsule, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68180058901
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: Active pharmaceutical ingredient was sourced from an unapproved vendor
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Reason Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
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