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FDAMay 21, 2019drug

Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. bottle, NDC: 0904-0053-09, c) 16 oz. bottle, NDC:0904-0053-16, Distributed by Major Pharmaceuticals Inc., 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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