FDA-Drug2019-08-14Class II

CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC 050428597156

Unipharma, Llc.
Hazard

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

Sold states
Nationwide in the US.
Affected count
48 cartons
Manufactured in
10200 NW 67th St, N/A, Tamarac, FL, United States
Products
CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC 050428597156

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1631-2019

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief