FDAJune 10, 2019drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

preferred pharmaceuticalspreferred

UPCs

68788084101

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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