Robafen DM recalled over manufacturing violations

Recall date

June 10, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Preferred Pharmaceuticals, Inc recalls Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100m…

Recall number

D-1410-2019

FDA classification

Class II

Brand / firm

Preferred Pharmaceuticals, Inc

Sold / distributed

Distribution was made to CA and FL.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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