The Recall Desk
SevereFDA (Drugs)·D-1380-2019·Announced 2019-06-19

Torrent Pharma Recalls Cetirizine Hydrochloride Oral Solution Due to Contamination Risk

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, which corresponds to a Severe rating under the rubric, particularly given the potential for significant injury from bacterial contamination in an injectable or oral solution context.

Plain-English summary

Torrent Pharma Inc. is recalling 1,126,404 bottles of Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, 120 mL bottles (NDC 23155-292-51). The product was manufactured for Heritage Pharmaceuticals Inc. and distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.

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 lots include specific expiration dates ranging from May 2019 to March 2020, as detailed in the recall notice.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, it should be discontinued and returned to the distributor or pharmacy of purchase.

The recalled product

Product
Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724.
Manufacturer
Torrent Pharma Inc
Category
Drug — Antihistamine
Hazard
Affected units
1,126,404

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: 17E021
  • 17E023
  • 17E040
  • 17E042
  • Exp. 05/2019
  • 17F017
  • Exp. 06/2019
  • 17G030
  • 17G033
  • Exp. 07/2019
  • 17H013
  • Exp. 08/2019
  • 17J007
  • 17J024
  • Exp. 09/2019
  • 17K003
  • 17K011
  • Exp. 10/2019
  • 17L016
  • 17L022

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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