Torrent Pharma Inc recalls Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown

Recalled June 19, 2019 · FDA recall D-1362-2019 · Torrent Pharma

Hazard

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

Units

14,016 bottles

Sold at

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

Description

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

Product

Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.

Manufacturer(s)

Torrent Pharma Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →