Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Dippin' Dots Scented Birthday Cake Antibacterial Hand Gel
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
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
DIPPIN' DOTS SCENTED BIRTHDAY CAKE ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Drug: Alcohol
- Recalling firm
- NingBo Huize Commodity Co.,Ltd.
- Origin
- N/A, China
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1561-2019 · 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 NingBo Huize Commodity Co.,Ltd.
All 2019 recalls
Class III · Low risk
Lemon Hand Sanitizer
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Dippin' Dots Scented Cotton Candy Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Dippin' Dots Scented Cookies 'N Cream Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Dippin' Dots Scented Banana Split Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
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