Multi-event April 2013 FDA Recall Drug by Total Resources Intl
This Multi-event Class II drug recall was voluntarily initiated by Total Resources Intl on April 9, 2013 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-891-2013
CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.
04-09-2013
08-21-2013
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.
Total Resources Intl
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-07-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
(No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789
Batch or Lot Expiration Information
Lot# Item Number 20-HBC-01015CCREV1.
Recall Number: D-889-2013
CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.
04-09-2013
08-21-2013
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.
Total Resources Intl
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-07-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789
Batch or Lot Expiration Information
Lot# Lot 11215-05,11216-05, 11216-06, 11217-05
Recall Number: D-890-2013
CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.
04-09-2013
08-21-2013
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.
Total Resources Intl
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-07-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport, Total Resources International, Walnut, CA 91789
Batch or Lot Expiration Information
Lot# Lot 11214-07
