Torrent Pharma Inc recalls Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0
Recalled June 19, 2019 · FDA recall D-1351-2019 · Torrent Pharma
Hazard
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). · FDA Class II
Units
1,500,672 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
Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. bottle, NDC: 0904-0053-09, c) 16 oz. bottle, NDC:0904-0053-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
Manufacturer(s)
Torrent Pharma Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →