Torrent Pharma Inc recalls Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Ph

Recalled June 19, 2019 · FDA recall D-1358-2019 · Torrent Pharma

Hazard

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

Units

66,798 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

Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Pharma, Skokie, IL 60076.

Manufacturer(s)

Torrent Pharma Inc

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