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FDAMay 21, 2019drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

torrent pharmatorrent

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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