Medications & Supplements/Over-the-Counter

P & L Developments, LLC: Children's Cetirizine Allergy Solutions Recalled for Bacterial Contamination

Agency Publication Date: June 20, 2019

Summary

Approximately 344,244 bottles of Children's Cetirizine HCL Oral Solution (1 mg/mL) sold under various brand names like Quality Choice and Up & Up are being recalled. P & L Developments, LLC initiated this recall after their supplier notified them of potential contamination with bacteria known as Burkholderia cepacia and Ralstonia pickettii. These 4-ounce grape-flavored allergy medications were sold nationwide at major retailers like Target and Dollar General.

Risk

The product may be contaminated with B. cepacia and R. pickettii bacteria, which can cause serious, life-threatening infections in people with weakened immune systems or chronic lung diseases. While no injuries have been reported, these bacteria are known to be resistant to many common antibiotics, making any resulting infection difficult to treat.

What You Should Do

Locate your bottle of Children's Cetirizine Oral Solution (4 fl. oz.) and check the brand and NDC/UPC codes on the label.
For Children's Allergy (Dolgencorp/Dollar General), check for NDC 55910-878-04, UPC 359726178051, and lot numbers 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, or F23239 (Exp. 8/20).
For Quality Choice (C.D.M.A. Inc.), check for NDC 63868-430-04, UPC 635515992474, and lot numbers C04866, C09863 (Exp. 10/19), F01267 (Exp. 12/19), F12609 (Exp. 2/20), or F25327 (Exp. 8/20).
For Up & Up (Target), check for NDC 11673-178-04, UPC 359726178044, and lot numbers A98495, C03882, A49664 (Exp. 5/19), C06541 (Exp. 6/19), C05532, F00527 (Exp. 10/19), F00528, F07279 (Exp. 12/19), F07842, or F10237 (Exp. 2/20).
Immediately stop using the product if it matches any of the identifiers above. Contact your healthcare provider or pharmacist for guidance regarding alternative medications and health concerns.
Return any unused portion of the product to the place of purchase for a full refund and contact P & L Developments, LLC for further instructions.
Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Full Refund

Full refund upon return.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Children's Allergy Cetirizine HCL Oral Solution 1 mg/mL, Dye Free, Grape Flavor (4 FL. oz.)

Model:

NDC 55910-878-04

UPC Codes:

359726178051

Lot Numbers:

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)

Date Ranges: Expiration dates between 05/2019 and 08/2020

Product: Quality Choice Children's Allergy Cetirizine Oral Solution 1 mg/mL, Dye Free, Grape Flavor (4 FL. oz.)

Model:

NDC 63868-430-04

UPC Codes:

635515992474

Lot Numbers:

C04866

C09863 (Exp. 10/19)

F01267 (Exp. 12/19)

F12609 (Exp. 2/20)

F25327 (Exp. 8/20)

Date Ranges: Expiration dates between 10/2019 and 08/2020

Product: Up & Up Children's Allergy Relief Cetirizine Oral Solution 1 mg/mL, Dye Free, Grape Flavor (4 FL. oz.)

Model:

NDC 11673-178-04

UPC Codes:

359726178044

Lot Numbers:

A98495

C03882

A49664 (Exp. 5/19)

C06541 (Exp. 6/19)

C05532

F00527 (Exp. 10/19)

F00528

F07279 (Exp. 12/19)

F07842

F10237 (Exp. 2/20)

Date Ranges: Expiration dates between 05/2019 and 02/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83181

Status: Resolved

Manufacturer: P & L Developments, LLC

Sold By: Dollar General; Target; C.D.M.A. Inc.

Manufactured In: United States

Units Affected: 3 products (202,068 bottles; 17,664 bottles; 124,512 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Locate your bottle of Children's Cetirizine Oral Solution (4 fl. oz.) and check the brand and NDC/UPC codes on the label.

For Children's Allergy (Dolgencorp/Dollar General), check for NDC 55910-878-04, UPC 359726178051, and lot numbers 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, or F23239 (Exp. 8/20).

For Quality Choice (C.D.M.A. Inc.), check for NDC 63868-430-04, UPC 635515992474, and lot numbers C04866, C09863 (Exp. 10/19), F01267 (Exp. 12/19), F12609 (Exp. 2/20), or F25327 (Exp. 8/20).

For Up & Up (Target), check for NDC 11673-178-04, UPC 359726178044, and lot numbers A98495, C03882, A49664 (Exp. 5/19), C06541 (Exp. 6/19), C05532, F00527 (Exp. 10/19), F00528, F07279 (Exp. 12/19), F07842, or F10237 (Exp. 2/20).

Immediately stop using the product if it matches any of the identifiers above. Contact your healthcare provider or pharmacist for guidance regarding alternative medications and health concerns.

Return any unused portion of the product to the place of purchase for a full refund and contact P & L Developments, LLC for further instructions.

Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Affected Products

Product: Children's Allergy Cetirizine HCL Oral Solution 1 mg/mL, Dye Free, Grape Flavor (4 FL. oz.)

Model:

NDC 55910-878-04

UPC Codes:

359726178051

Lot Numbers:

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)

Date Ranges: Expiration dates between 05/2019 and 08/2020

Product: Quality Choice Children's Allergy Cetirizine Oral Solution 1 mg/mL, Dye Free, Grape Flavor (4 FL. oz.)

Model:

NDC 63868-430-04

UPC Codes:

635515992474

Lot Numbers:

C04866

C09863 (Exp. 10/19)

F01267 (Exp. 12/19)

F12609 (Exp. 2/20)

F25327 (Exp. 8/20)

Date Ranges: Expiration dates between 10/2019 and 08/2020

Product: Up & Up Children's Allergy Relief Cetirizine Oral Solution 1 mg/mL, Dye Free, Grape Flavor (4 FL. oz.)

Model:

NDC 11673-178-04

UPC Codes:

359726178044

Lot Numbers:

A98495

C03882

A49664 (Exp. 5/19)

C06541 (Exp. 6/19)

C05532

F00527 (Exp. 10/19)

F00528

F07279 (Exp. 12/19)

F07842

F10237 (Exp. 2/20)

Date Ranges: Expiration dates between 05/2019 and 02/2020