Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD52993_19, EXP: 5/20/2014.
D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348041010
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 Chemical contamination; presence of lead and lithium above specification
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Reason Lack of Assurance of Sterility
Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Reason Subpotent drug
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