The Recall Desk
SevereFDA (Drugs)·D-1371-2019·Announced 2019-06-19

Torrent Pharma Recalls Nasal Decongestant Liquid Due to Bacterial Contamination

Torrent Pharma Inc is recalling specific lots of Nasal Decongestant Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While the source text does not explicitly state hospitalizations, the presence of specific bacterial contamination in a drug product typically warrants a higher severity classification under the 'Severe' criteria for significant risk.

Plain-English summary

Torrent Pharma Inc is recalling 62,748 bottles of Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536-1850-97. The product is distributed by Rugby Laboratories in Livonia, MI. The recall is due to cGMP deviations that resulted in potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

The affected lots are 17G002 (Exp. 07/2019), 17H024 (Exp. 08/2019), 17M023 (Exp. 12/2019), and 18F012 (Exp. 06/2020). The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.

Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or return.

The recalled product

Product
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.
Manufacturer
Torrent Pharma Inc
Category
Drug — Liquid OTC
Hazard
Affected units
62,748

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Lot #s: 17G002
  • Exp. 07/2019
  • 17H024
  • Exp. 08/2019
  • 17M023
  • Exp. 12/2019
  • 18F012
  • Exp. 06/2020.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 41 recalled by Torrent Pharma Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 41 products in this recall →

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