FDAClass IIAugust 14, 2019

DrKids Children's Allergy Relief Diphenhydramine HCl recall: CGMP Deviations

DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton…

Why was DrKids Children's Allergy Relief Diphenhydramine HCl recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 90003 Exp. 01/31/21

Product
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton…
Recalling firm
Unipharma, Llc.
Quantity
432 cartons
Distribution
Nationwide in the US.
Recall date
August 14, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls