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

Recall Number: D-1410-2019

Firm: Preferred Pharmaceuticals, Inc

Classification: Class II

Status: Terminated

Report Date: 20190626

Initiation Date: 20190610

Termination Date: 20230403

CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

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