Safecor Health, LLC — Class II: Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in car
Safecor Health, LLC has initiated a Class II recall for Atomoxetine HCl 10 mg capsules because 25 mg capsules were incorrectly labeled as the 10 mg strength. The affected product is distributed in unit-dose foil strips within cartons of 100.
This affects Safecor Health, LLC, pharmacy distributors, and healthcare facilities utilizing repackaged unit-dose Atomoxetine HCl. Regulatory and Quality departments at contract repackaging facilities are primarily impacted.
A labeling mix-up involving different potencies (25 mg labeled as 10 mg) represents a significant medication error risk. From a regulatory perspective, this suggests a potential failure in labeling controls or line clearance procedures during the repackaging process. Ongoing status indicates that reconciliation and retrieval efforts are currently active.
QA teams should review line clearance protocols and vision system validation for unit-dose packaging lines. Compliance officers should ensure that reconciliation procedures at the repackaging stage are sufficient to detect potency discrepancies between bulk stock and final labeled output.
Class II. Reason: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.. Product: Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01. Firm: Safecor Health, LLC (Columbus OH United States). Status: Ongoing.
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