Class II · Moderate risk
(No Brand) First Aid Kit
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.
3M Tekk Brand Industrial/Construction First Aid Kit
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789
- Recalling firm
- Total Resources Intl
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-889-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Total Resources Intl
All 2013 recalls
Class II · Moderate risk
Medi-First Brand First Aid Kit
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.
Other stability / shelf life recalls from 2013
All stability / shelf life recalls
Class III · Low risk
VoLumen Barium Sulfate Suspension
Failed Stability Testing: This product is below specification for preservative content.
Class III · Low risk
Fluconazole Oral Suspension
Failed Stability Specifications: this product is below specification for preservative content.
Class III · Low risk
Acyclovir Oral Suspension
Failed Stability Specification; product viscosity and or pH are below specification.
Class III · Low risk
Tagitol V Barium Sulfate Suspension
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
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