Torrent Pharma Inc recalls Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, N
Recalled June 19, 2019 · FDA recall D-1376-2019 · Torrent Pharma
Hazard
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). · FDA Class II
Units
140,436 suppositories
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
Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, NDC: 59741-301-12, b) 24 Adult Suppositories per carton, NDC: 59741-301-24, Manufactured by Bio-Pharm Inc., Levittown PA 19057.
Manufacturer(s)
Torrent Pharma Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →