Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #s: C00138; A48440, Exp. 5/19; C02434; C04186, Exp. 6/19; C07864, Exp. 7/19; F13277; C08962; F13778, Exp. 10/19; C11746; F05899; F13777, Exp. 12/19; F09356; F10784; F13595, Exp. 2/20; F22355; F23239, Exp. 8/20.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- P & L Developments, LLC
- Reason for Recall:
- cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential 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 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051.
Product Codes/Lot Numbers:
Lot #s: C00138; A48440, Exp. 5/19; C02434; C04186, Exp. 6/19; C07864, Exp. 7/19; F13277; C08962; F13778, Exp. 10/19; C11746; F05899; F13777, Exp. 12/19; F09356; F10784; F13595, Exp. 2/20; F22355; F23239, Exp. 8/20.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1407-2019
Related Recalls
Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3.
P & L Developments
Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).