The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1354-2019·Announced 2019-06-19

Torrent Pharma Recalls Nasal Decongestant Spray Due to Potential Bacterial Contamination

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

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a 'Severe' rating under the rubric, particularly given the potential for significant injury from bacterial contamination in a nasal spray.

Plain-English summary

Torrent Pharma Inc is voluntarily recalling specific lots of Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, in 0.5 FL. oz. (15 mL) and 1 FL. oz. (30 mL) bottles. The recall involves 3,788,502 bottles distributed by Major Pharmaceuticals, Livonia MI 48152.

The recall was initiated due to cGMP deviations that resulted in potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The affected 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 bottles for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
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.
Manufacturer
Torrent Pharma Inc
Category
Drug — Nasal Spray
Hazard
Affected units
3,788,502

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 (20)

  • Lot #s: a) 17E032
  • Exp. 05/2019
  • 17F011
  • 17F020
  • Exp. 06/2019
  • 17G003
  • 17G011
  • Exp. 07/2019
  • 17H016
  • Exp. 08/2019
  • 17J005
  • 17J017
  • 17J026
  • Exp. 09/2019
  • 17K029
  • Exp. 10/2019
  • 17L027
  • Exp. 11/2019
  • 18A003
  • 18A004

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 →

Related recalls

Same manufacturer · Torrent Pharma Inc

See all →

Same hazard · bacterial contamination

See all →

Similar recalls