D-1631-2019 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
- 48 cartons
Product Description
CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC 050428597156
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: 80060 Exp. 11/30/20