Torrent Pharma Inc recalls Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC:

Recalled June 19, 2019 · FDA recall D-1379-2019 · Torrent Pharma

Hazard

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). · FDA Class II

Units

177,408 bottles

Sold at

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

Description

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Product

Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Manufacturer(s)

Torrent Pharma Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →