Nasal Decongestant Spray Regular 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 Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle, NDC:0904-5711-35, b) 1 FL. oz…

Recall number

D-1354-2019

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

Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle, NDC:0904-5711-35, b) 1 FL. oz. (30 mL) bottle, NDC: 0904-5711-30, Distributed by Major Pharmaceuticals, Livonia MI 48152.