D-1299-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2019
- Initiation Date
- May 2, 2019
- Termination Date
- November 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 280 cartons
Product Description
DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL), Cherry Flavor, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-011-20, UPC 370302223019
Reason for Recall
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Distribution Pattern
Nationwide and Venezuela
Code Information
Lots: 80061 Exp. 11/30/20