Preferred Pharmaceuticals, Inc recalls Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg
Recalled June 26, 2019 · FDA recall D-1410-2019 · Preferred Pharmaceuticals
Hazard
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). · FDA Class II
Units
192 4 oz bottles
Sold at
Distribution was made to CA and FL.
Description
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01
Manufacturer(s)
Preferred Pharmaceuticals, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →