Lack of Assurance of Sterility
Drugs Recalls
Prescription and over-the-counter medications
Pain Stopper, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Herbal Doctor Remedies
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Glauco-Catar Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Herbal Doctor Remedies
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Stone Purger Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Herbal Doctor Remedies
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
DIPPIN' DOTS SCENTED COTTON CANDY 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.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
TOOTSIE ROLL FRUIT CHEWS 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.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Lack of Processing Controls
ICEE CHERRY 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.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
ICEE BLUE RASPBERRY 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.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
TOOTSIE ROLL FRUIT CHEWS VANILLA 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.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Microbial contamination of non-sterile product
Subpotent Drug
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
Wise Pharmacy
Lack of Processing Controls
DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
NingBo Huize Commodity Co.,Ltd.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CHARMS BLOW POP WATERMELON 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.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
AIR HEADS BLUE RASPBERRY 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.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
AIR HEADS STRAWBERRY 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.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.