FDAClass IIMay 22, 2019

CVS Health Children's Cough Syrup English Ivy Leaf recall: CGMP Deviations

CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958

Why was CVS Health Children's 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?

Lots: 80043 Exp. 07/05/20; 80047 Exp. 07/31/20

Product
CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958
Recalling firm
Unipharma, Llc.
Quantity
38640 cartons
Distribution
Nationwide and Venezuela
Recall date
May 22, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls