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Class II: temporary or reversible health riskTerminated

Unipharma DrKids Children's Allergy Relief Recall

DrKids Children's Allergy Relief Diphenhydramine HCl 12

Unipharma, Llc. · Tamarac, FL

Risk level
Class II
Reported by FDA
May 22, 2019
Recall ID
D-1298-2019
Check your lot numberHow we source this data

Summary

Unipharma recalled DrKids Children's Allergy Relief starting May 2, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1298-2019 on May 22, 2019. Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. Status: Terminated.

Why it was recalled

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Product 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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide and Venezuela

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1298-2019
Classification
Class II
Status
Terminated
Recall initiated
May 2, 2019
FDA report date
May 22, 2019
Quantity
1060 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Unipharma, Llc.

Original FDA data

Every field from FDA enforcement report D-1298-2019, exactly as published.

Show all FDA fields
City
Tamarac
State
FL
Status
Terminated
Country
United States
Event ID
82754
Address
10200 NW 67th St
Code information
Lots: 80058; 80060, Exp. 11/30/20
Postal code
33321-6404
Report date
May 22, 2019
Product type
Drugs
Recall number
D-1298-2019
Classification
Class II
Recalling firm
Unipharma, Llc.
Product quantity
1060 cartons
Termination date
Nov 25, 2020
Reason for recall
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Voluntary / mandated
Voluntary: Firm initiated
Product 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
Distribution pattern
Nationwide and Venezuela
Recall initiation date
May 2, 2019
Initial firm notification
Letter
Center classification date
May 23, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1298-2019, published May 22, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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