Torrent Pharma Inc recalls Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle,

Recalled June 19, 2019 · FDA recall D-1368-2019 · Torrent Pharma

Hazard

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

Units

249,744 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

Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152.

Manufacturer(s)

Torrent Pharma Inc

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