FDA-Drug2019-05-22Class 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 0.17 fl. oz. (5 mL), 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 and Venezuela
Affected count
27840 cartons
Manufactured in
10200 NW 67th St, 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 0.17 fl. oz. (5 mL), 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-1300-2019

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