Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as one of the following drugs: PANCRELIPASE DR, Capsule, 0 mg, NDC 42865010302, Pedigree: W003354, EXP: 6/19/2014; acetaZOLAMIDE, Tablet, 250 mg, NDC 51672402301, Pedigree: W003524, EXP: 6/21/2014; METOPROLOL TARTRATE, Tablet, 25 mg, NDC 00378001801, Pedigree: W002535, EXP: 6/3/2014; RIVAROXABAN, Tablet, 20 mg,
ASPIRIN, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536330501.
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: Observations were made that some blister card-foils were separating from the blister cavity.
Reason Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Reason Failed Tablet/Capsule Specification : Capsule breakage
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations
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