Class I - Dangerous
cGMP deviations
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.
KENIL HEALTHCARE PRIVATE LIMITED
Class I - Dangerous
CGMP Deviations
KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.
KENIL HEALTHCARE PRIVATE LIMITED
Class I - Dangerous
CGMP Deviations
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9.
KENIL HEALTHCARE PRIVATE LIMITED
Class I - Dangerous
CGMP Deviations
KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3.
KENIL HEALTHCARE PRIVATE LIMITED
Class I - Dangerous
CGMP Deviations
Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01
KENIL HEALTHCARE PRIVATE LIMITED
Class I - Dangerous
CGMP Deviations
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.
KENIL HEALTHCARE PRIVATE LIMITED
Class I - Dangerous
CGMP Deviations
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Class I - Dangerous
Lack of Assurance of Sterility
temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.
Siddha Flower Essences
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class I - Dangerous
cGMP deviations and lack of assurance of sterility.
Class I - Dangerous
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class I - Dangerous
Presence of Particulate Matter
Presence of Particulate Matter: Glass particles were found in pellet vials.
Class I - Dangerous
cGMP deviations and lack of assurance of sterility.
Presence of Particulate Matter: Glass particles were found in pellet vials.