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FDAMay 21, 2019drug

Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-0061-00, b) One Pint ( 473 mL) bottle, NDC: 0904-0061-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.

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

torrent pharmatorrent

Recall history

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

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