🔍 RecallPedia

DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 370302255010

Class I - Dangerous
💊 Drugs Recalled: May 2, 2019 Unipharma Over-the-Counter Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: 80058; 80060, Exp. 11/30/20
  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:
Unipharma, Llc.
Reason for Recall:
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 370302255010

Product Codes/Lot Numbers:

Lots: 80058; 80060, Exp. 11/30/20

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1298-2019

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