FDA recall D-0132-2020

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

Reason for recall

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

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2019-09-23

Report date

2019-10-16

Termination date

2021-03-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tamarac, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0132-2020