Apotex Inc: CGMP Deviations: Apotex, Inc. Ontario, Canada is recalling 73 pharmaceutical products manufactured in a facility with significant cGMP deficiencies.

Agency: Food and Drug Administration (FDA)

Event ID: 53088

Status: Resolved

Manufacturer: Apotex Inc

Manufactured In: Canada

Units Affected: 73 products (2,021 bottles; 10,213 bottles; 4,609 bottles; 23,890 bottles; 25,187 bottles; 5,062 bottles; 27,242 bottles; 32,811 bottles; 74,992 bottles; 22,804 bottles; 89,139 bottles; 8,228 bottles; 4,863 bottles; 766 bottles; 3,099 bottles; 203,832 bottles; 30,985 bottles; 7,504 bottles; 26,521 bottles; 7,764 bottles; 27,553 bottles; 30,037 bottles; 22,482 bottles; 90,084 bottles; 40,979 bottles; 66,299 bottles; 36,308 bottles; 12,203 bottles; 11,295 bottles; 16,646 bottles; 8,732 bottles; 12,761 bottles; 317,180 bottles; 46,024 bottles; 30,608 bottles; 18,246 bottles; 11,598 bottles; 1,601 bottles; 1,459 bottles; 1,738 bottles; 666 bottles; 169,533 bottles and boxes; 97,143 bottles and boxes; 74,584 bottles; 169,348 bottles; 485,838 bottles; 31,768 bottles; 164,308 bottles; 89,344 bottles and boxes; 39,024 bottles; 2062 bottles; 24,466 bottles and boxes; 130,090 bottles; 25,322 bottles; 312 bottles; 86,283 bottles; 44,134 bottles; 85,665 bottles; 138,401 bottles; 3,708 bottles; 370,146 bottles; 99,676 bottles; 247,398 bottles; 29,465 bottles; 31,670 bottles; 12,191 bottles; 94,461 bottles; 171,770 bottles and boxes; 20,260 bottles; 34,412 bottles; 12,305 bottles and boxes; 3,443 bottles; 173,642 bottles)