Hydrocortisone Acetate Suppositories recalled over manufacturing violations

Recall date

May 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Torrent Pharma Inc recalls Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton,…

Recall number

D-1376-2019

FDA classification

Class II

Brand / firm

Torrent Pharma Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.