Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Nasal Decongestant Liquid Recalled by Torrent Pharma Inc Due to cGMP Deviations: Potential product contamination with Burkholderia cepacia...

Date: May 21, 2019
Company: Torrent Pharma Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Torrent Pharma Inc directly.

Affected Products

Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536-1850-97, Distributed by Rugby Laboratories, Livonia MI 48152.

Quantity: 62,748 bottles

Why Was This Recalled?

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

Where Was This Sold?

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

About Torrent Pharma Inc

Torrent Pharma Inc has 44 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report