March 2014 FDA Recall Drug by First Aid Only Inc (D-1323-2014 - 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).)
This Class II drug recall was voluntarily initiated by First Aid Only Inc on March 25, 2014 for the product Drug. The FDA reported the reason for recall as 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).. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1323-2014
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).
03-25-2014
05-21-2014
802
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
First Aid Only Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-11-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA
Batch or Lot Expiration Information
Lot# Aspirin was packed into Ibuprofen boxes (Item Number FAE-7014) coded: B11340515, B11840515, B12040615, B12540615, B12640615, B12740615, C10340615 and B11040516.