Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured…
Reason Failed Dissolution Specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: AD33897_4, EXP: 5/9/2014; FINASTERIDE, Tablet, 5 mg, NDC 16714052201, Pedigree: W003031, EXP: 2/28/2014.
ATORVASTATIN CALCIUM, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378212177 .
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 Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Failed dissolution specifications: lower than specifications
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