FDA recall D-1379-2019

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-05-21

Report date

2019-06-19

Termination date

2020-10-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Levittown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1379-2019