Medications & Supplements/Over-the-Counter

Unipharma, Llc.: Natural Cough Syrup and Nasal Saline Recalled for Bacteria Risk

Agency Publication Date: October 9, 2019

Summary

Unipharma, LLC is recalling 600 cartons of DrKids Children's Natural Cough Syrup and DrKids Himasal Natural Nasal Saline Solution due to manufacturing deviations that could lead to contamination with B. cepacia bacteria. The recall includes 144 cartons of English Ivy Leaf cough syrup and 456 cartons of nasal saline vials. These products were distributed nationwide in the U.S. and were manufactured in Tamarac, Florida.

Risk

The products may be contaminated with B. cepacia, a bacteria that can cause serious or life-threatening respiratory infections in individuals with weakened immune systems or chronic lung diseases like cystic fibrosis.

What You Should Do

Check your medicine cabinet for DrKids Children's Natural Cough Syrup English Ivy Leaf (3.4 fl. oz.) with UPC 370302489026 and Lot number 80047 (Exp. 07/31/20).
Check for DrKids Himasal Natural Nasal Saline Solution in 0.5 mL (UPC 37030244608) or 1.5 mL (UPC 370302446098) vials with Lot numbers 80003 (Exp. 01/31/20), 70003 (Exp. 10/31/19), 70005 (Exp. 11/30/19), or 70006 (Exp. 11/30/19).
Stop using these recalled products immediately to avoid the risk of bacterial infection.
Contact your healthcare provider or pharmacist for guidance regarding use of these products.
Return any unused product to the place of purchase for a full refund and contact Unipharma, LLC at their Tamarac, FL facility for further instructions.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug product refund and medical consultation

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

Affected Products

Product: DrKids Children's Natural Cough Syrup English Ivy Leaf (3.4 fl. oz. / 100 mL)

Model:

Recall #: D-0132-2020

UPC Codes:

370302489026

Lot Numbers:

80047 (Exp. 07/31/20)

Date Ranges: Expiration date 07/31/20

Product: DrKids Himasal Natural Nasal Saline Solution (0.5 mL vials, 20 count)

Model:

Recall #: D-0133-2020

UPC Codes:

37030244608

Lot Numbers:

80003 (Exp. 01/31/20)

70003 (Exp. 10/31/19)

70005 (Exp. 11/30/19)

70006 (Exp. 11/30/19)

Date Ranges: Expiration date 01/31/20, Expiration date 10/31/19, Expiration date 11/30/19

Product: DrKids Himasal Natural Nasal Saline Solution (1.5 mL vials, 20 count)

Model:

Recall #: D-0133-2020

UPC Codes:

370302446098

Lot Numbers:

80003 (Exp. 01/31/20)

70003 (Exp. 10/31/19)

70005 (Exp. 11/30/19)

70006 (Exp. 11/30/19)

Date Ranges: Expiration date 01/31/20, Expiration date 10/31/19, Expiration date 11/30/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83881

Status: Resolved

Manufacturer: Unipharma, Llc.

Manufactured In: United States

Units Affected: 2 products (144 cartons; 456 cartons)

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

What You Should Do

Check your medicine cabinet for DrKids Children's Natural Cough Syrup English Ivy Leaf (3.4 fl. oz.) with UPC 370302489026 and Lot number 80047 (Exp. 07/31/20).

Check for DrKids Himasal Natural Nasal Saline Solution in 0.5 mL (UPC 37030244608) or 1.5 mL (UPC 370302446098) vials with Lot numbers 80003 (Exp. 01/31/20), 70003 (Exp. 10/31/19), 70005 (Exp. 11/30/19), or 70006 (Exp. 11/30/19).

Stop using these recalled products immediately to avoid the risk of bacterial infection.

Contact your healthcare provider or pharmacist for guidance regarding use of these products.

Return any unused product to the place of purchase for a full refund and contact Unipharma, LLC at their Tamarac, FL facility for further instructions.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: DrKids Children's Natural Cough Syrup English Ivy Leaf (3.4 fl. oz. / 100 mL)

Model:

Recall #: D-0132-2020

UPC Codes:

370302489026

Lot Numbers:

80047 (Exp. 07/31/20)

Date Ranges: Expiration date 07/31/20

Product: DrKids Himasal Natural Nasal Saline Solution (0.5 mL vials, 20 count)

Model:

Recall #: D-0133-2020

UPC Codes:

37030244608

Lot Numbers:

80003 (Exp. 01/31/20)

70003 (Exp. 10/31/19)

70005 (Exp. 11/30/19)

70006 (Exp. 11/30/19)

Date Ranges: Expiration date 01/31/20, Expiration date 10/31/19, Expiration date 11/30/19

Product: DrKids Himasal Natural Nasal Saline Solution (1.5 mL vials, 20 count)

Model:

Recall #: D-0133-2020

UPC Codes:

370302446098

Lot Numbers:

80003 (Exp. 01/31/20)

70003 (Exp. 10/31/19)

70005 (Exp. 11/30/19)

70006 (Exp. 11/30/19)

Date Ranges: Expiration date 01/31/20, Expiration date 10/31/19, Expiration date 11/30/19