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.

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

Code information: Lot #s: 17L008, Exp. 05/2019; 17M019; 17M037, Exp. 06/2019; 18B012; 18K023, Exp. 04/2020.

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