Is Tri Vitamins with Fluoride Chewable Tablets, Vitamin A 2500 IU, Vitamin C 60 mg, Vitamin D 400 IU, Fluoride 1.0 mg, 100 tablets, Rx only, Actavis, Totowa, NJ, Also manufactured for Qualitest, Huntsville, AL and Major Pharmaceuticals, Livonia, MI recalled?

Medium RiskFDA Drug

Actavis Totowa LLC: cGMP Deviations; lack of impurity testing on stability; cGMP Deviations; cGMP Deviation

Agency Publication Date: September 11, 2008

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 48643

Status: Resolved

Manufacturer: Actavis Totowa LLC

Manufactured In: United States

Units Affected: 41 products (6 lots: 39076 bottles Amide/Actavis; 6094 bottles Qualitest; 2160 bottles Major. 100 tablets per bottle; 19 lots; Actavis/Amide: 103,572 bottles; Warner Chilcott: 3695 bottles; 39 lots; 243,840 bottle Actavis/Amide; 10029 bottles Warner Chilcott; 1 lot , 7200 bottles; 3 lots: 26346 bottles; 4 lots; 100 count - 5280 bottles; 500 count bottles - 2895 bottles; 10 lots, 25,777 bottles; 3 lots 17,779 bottles; 13 lots, 109,986 bottles; 6 lots, 49279 bottles; 28 lots Amide/Actavis: 88529 bottles - Major 2360 bottles, Ivax 9480 bottles, Everett Labs: 15840 bottles; 42 lots; 205,770 bottles; 14 lots; 109,837 bottles; 11 lots; 31090 bottles.; 11 lots; 47,075 bottles; 1 lot - 2474 bottles; 29 lots; 124871 bottles; 39 lots; 161369 bottles.; 11 lots; 116961 bottles; 23 lots; 168840 bottles; 13 lots, 73684 bottles; 18 lots; 66458 bottles; 10 lots, 16668 100 count bottles, 13104 500 count bottles; 6 lots; 23743 bottles; 24 lots; 236, 181 bottles; 26 lots; 344394 bottles; 16 lots; 174780 bottles; 27 lots; 51,708,777 tablets; 49 lots, 1,490,189 bottles; 22 lots; 103623 bottles; 12 lots; 58092 bottles; 2 lots; 3925 bottles,; 83 lots; 287960 bottles; 1 lot, 25700 bottles; 10 lots; 154,803 packets; 10 lots; 21433 bottles; 4 lots; 25,563 bottles; 1 lot; 2517 bottles; 1 lot; 17,063 bottles; 1 lot: 16602 bottles; 3 lots; 10223 blister packs)

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Sources: FDA iRES · Raw API Response

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