FDA-Drug2019-06-19Class II
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.
Torrent Pharma Inc
Hazard
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Sold states
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Affected count
176,580 bottles
Manufactured in
2091 Hartel Ave, N/A, Levittown, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1369-2019Don't want to check this manually?
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