Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
I love sleep overs Justice
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
I love sleep overs Justice, Grape anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
Drug: Alcohol
- Recalling firm
- Tween Brands Inc
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-356-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Alcohol recalls
See all
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Other recalls by Tween Brands Inc
All 2013 recalls
Class III · Low risk
BFF's are COOL! Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
yum yum bubble gum Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
YOU CANT HANDLE THIS Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
I LOVE BACON Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
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