The Recall Desk
SevereFDA (Drugs)·D-1381-2019·Announced 2019-06-19

Torrent Pharma Recalls Cetirizine Hydrochloride Oral Solution Due to Contamination

Torrent Pharma Inc. is recalling specific lots of Cetirizine Hydrochloride 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 the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While specific injury reports are not detailed in the provided text, the presence of bacterial contamination in an oral solution warrants a high severity rating consistent with Class II classifications involving potential harm.

Plain-English summary

Torrent Pharma Inc. is recalling 730,476 bottles of Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, 120 mL bottles. The recall involves specific lots of NDC 13668-029-07 and NDC 13668-596-07 manufactured by Bio-Pharm, Inc. for Torrent Pharma Inc.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations that resulted in potential product contamination with Burkholderia cepacia and Ralstonia 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 and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the distributor or pharmacy of purchase for a refund or replacement.

The recalled product

Product
Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..
Manufacturer
Torrent Pharma Inc
Category
Drug — Oral Solution
Hazard
Affected units
730,476

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) Lot #: 18D027
  • 18D028
  • 18D029
  • Exp. 04/2020. b) 18D029A
  • Exp. 04/2020
  • 18E001B
  • 18E010B
  • Exp. 05/2020
  • 18F016A
  • 18F017A
  • 18F037A
  • Exp. 06/2020
  • 18J021
  • 18J023
  • 18J023A
  • 18J024
  • Exp. 09/2020
  • 18K001
  • 18K002
  • Exp. 10/2020

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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