Class I - Dangerous
Subpotent Drug
💊
Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
CHARMS BLOW POP SOUR APPLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
NingBo Huize Commodity Co.,Ltd.
Class I - Dangerous
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
NingBo Huize Commodity Co.,Ltd.
Class I - Dangerous
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CHARMS BLOW POP BLUE RAZZ BERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
NingBo Huize Commodity Co.,Ltd.
Class I - Dangerous
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
TOOTSIE ROLL SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
NingBo Huize Commodity Co.,Ltd.
Class I - Dangerous
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
NingBo Huize Commodity Co.,Ltd.
Class I - Dangerous
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
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.
NingBo Huize Commodity Co.,Ltd.
Class I - Dangerous
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
DIPPIN' DOTS SCENTED BANANA SPLIT ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
NingBo Huize Commodity Co.,Ltd.
Class I - Dangerous
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
AIR HEADS ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
NingBo Huize Commodity Co.,Ltd.
Class I - Dangerous
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class I - Dangerous
Lack of Processing Controls
Class I - Dangerous
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
ICEE LEMON LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
NingBo Huize Commodity Co.,Ltd.
Class I - Dangerous
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class I - Dangerous
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China
NingBo Huize Commodity Co.,Ltd.
Class I - Dangerous
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class I - Dangerous
Lack of Processing Controls
Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Wise Pharmacy
Class I - Dangerous
Lack of Processing Controls
DOTS SCENTED ANTIBACTERIAL HAND GEL LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
NingBo Huize Commodity Co.,Ltd.
Class I - Dangerous
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class I - Dangerous
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
NingBo Huize Commodity Co.,Ltd.
Class I - Dangerous
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class I - Dangerous
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.