Why it was recalled
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.
Product description
(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
Lot numbers, UPCs & expiration codes
Item Number 20-HBC-01015CCREV1.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-891-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 9, 2013
- FDA report date
- Aug 21, 2013
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Total Resources Intl
Original FDA data
Every field from FDA enforcement report D-891-2013, exactly as published.
Show all FDA fields
- City
- City of Industry
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64929
- Address
- 420 S Lemon Ave Ste A
- Code information
- Item Number 20-HBC-01015CCREV1.
- Postal code
- 91789-2956
- Report date
- Aug 21, 2013
- Product type
- Drugs
- Recall number
- D-891-2013
- Classification
- Class II
- Recalling firm
- Total Resources Intl
- Termination date
- Jan 7, 2014
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- (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
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 9, 2013
- Initial firm notification
- Center classification date
- Aug 13, 2013