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FDAMay 21, 2019drug

Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by Rugby Laboratories, 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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