D-0132-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 16, 2019
- Initiation Date
- September 23, 2019
- Termination Date
- March 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144 cartons
Product Description
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 Pattern
U.S.A. Nationwide
Code Information
Lot: 80047 Exp. 07/31/20