Cough Syrup 200 mg/ recalled over manufacturing violations

Recall date

May 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Torrent Pharma Inc recalls Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle,…

Recall number

D-1368-2019

FDA classification

Class II

Brand / firm

Torrent Pharma Inc

Sold / distributed

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152.