Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Torrent Pharma Inc
Reason for Recall:
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1361-2019

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