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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

Unipharma, Llc.: Children's Allergy Relief and Saline Drops Recalled for Bacterial Risk

Agency Publication Date: August 8, 2019
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Summary

Unipharma, Llc. is recalling approximately 528 cartons of CVS Health Children's Allergy Relief, DrKids Children's Allergy Relief, and CVS Health Children's Nasal Saline Drops. The recall was initiated due to deviations from manufacturing standards that indicate a potential risk of contamination with the bacteria B. cepacia. These products are liquid medications and saline solutions packaged in single-use vials and were distributed nationwide across the United States.

Risk

The product may be contaminated with B. cepacia bacteria, which can cause serious infections, particularly in children or individuals with weakened immune systems. While no injuries have been reported, the bacteria can be resistant to common antibiotics and poses a significant health hazard if ingested or applied to sensitive nasal tissues.

What You Should Do

  1. Check your medicine cabinet for CVS Health Children's Allergy Relief (Lot 80060, UPC 050428597156), DrKids Children's Allergy Relief (Lot 90003, UPC 370302255010), or CVS Health Children's Nasal Saline Drops (Lot 90008, UPC 050428598207).
  2. Immediately stop using the affected products and set them aside where children cannot access them.
  3. Contact your healthcare provider or pharmacist for guidance regarding the use of these medications or if you have concerns about your child's health.
  4. Return any unused product to the pharmacy or place of purchase for a full refund.
  5. Contact Unipharma, Llc. for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund for unused medication

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

Affected Products

Product: CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Mixed Berry Flavor (3.4 fl. oz. / 100 mL)
Model:
NDC 69842-261-01
UPC Codes:
050428597156
Lot Numbers:
80060 (Exp. 11/30/20)
Product: DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor (20 single-use vials)
UPC Codes:
370302255010
Lot Numbers:
90003 (Exp. 01/31/21)
Product: CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer (1.5 fl. oz. / 45 mL)
UPC Codes:
050428598207
Lot Numbers:
90008 (Exp. 02/28/21)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83492
Status: Resolved
Manufacturer: Unipharma, Llc.
Sold By: CVS Pharmacy; CVS Pharmacy, Inc.
Manufactured In: United States
Units Affected: 3 products (48 cartons; 432 cartons; 48 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 ยท 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.