Banophen Oral Solution 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 Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains d…

Recall number

D-1352-2019

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

Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains diphenhydramine hydrochloride, USP 12.5 mg, a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-1228-00, b) One Pint (473 mL) bottle, NDC: 0904-5174-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.