Torrent Pharma Inc recalls Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Sk

Recalled June 19, 2019 · FDA recall D-1359-2019 · Torrent Pharma

Hazard

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

Units

53,520 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

Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076.

Manufacturer(s)

Torrent Pharma Inc

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