FDA-Drug2019-06-19Class II
Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.
Torrent Pharma Inc
Hazard
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Sold states
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Affected count
82,872 bottles
Manufactured in
2091 Hartel Ave, N/A, Levittown, PA, United States
Products
Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1378-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief