The Recall Desk
SevereFDA (Drugs)·D-1361-2019·Announced 2019-06-19

Torrent Pharma Recalls Cetirizine HCL Oral Solution Due to Contamination

Torrent Pharma Inc is recalling Cetirizine HCL Oral Solution 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 involves potential contamination with specific bacterial pathogens (Burkholderia cepacia and Ralstonia pickettii), which aligns with the rubric criteria for Severe severity involving significant health risks or Class II classifications with potential for adverse health consequences.

Plain-English summary

Torrent Pharma Inc is recalling 361,260 bottles of Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD. The recall was initiated due to current Good Manufacturing Practice (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. The recall covers specific lots with expiration dates ranging from May 2019 to August 2020.

Consumers should check their inventory for the specific lot numbers listed in the recall notice and stop using the product if it matches. The FDA classifies this as a Class II recall, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD
Manufacturer
Torrent Pharma Inc
Category
Drug — Oral Solution
Hazard
Affected units
361,260

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 (16)

  • Lot #s: 17E015
  • 17E024
  • 17E044
  • Exp. 05/2019
  • 17F018
  • Exp. 06/2019
  • 17G012
  • Exp. 07/2019
  • 17K024
  • Exp. 10/2019
  • 17M004
  • Exp. 12/2019
  • 18B017
  • Exp. 02/2020
  • 18H023
  • Exp. 08/2020.

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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