D-1632-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 14, 2019
- Initiation Date
- July 15, 2019
- Termination Date
- June 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 432 cartons
Product Description
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302255010
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 in the US.
Code Information
Lot: 90003 Exp. 01/31/21