FDAClass IIOctober 16, 2019

DrKids Children's Natural Cough Syrup English Ivy Leaf recall: CGMP Deviations

DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026

Why was DrKids Children's Natural Cough Syrup English Ivy Leaf 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: 80047 Exp. 07/31/20

Product
DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026
Recalling firm
Unipharma, Llc.
Quantity
144 cartons
Distribution
U.S.A. Nationwide
Recall date
October 16, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls