Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets).
Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA
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 Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Reason CGMP Deviations
Reason Failed Tablet/Capsule Specifications
Reason Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
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