CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL)
Summary
The FDA issued a Class III for CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor by New Vision Pharmaceuticals LLC. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0853-2021
Action Date
2021-10-06
Status
Terminated
Category
drug
Product Description
CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total NDC 69842-499-08 UPC 0 50428 64130 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895
Lot/Code Info: Lots: 2021-10154 Exp. 06/29/2023; 2021-10164 Exp. 06/11/2023
Quantity Affected: 18,864 FG cartons
Reason for Recall
Subpotent Drug
Distribution
AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-02
Company
Tamarac, FL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 107 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
New Vision Pharmaceuticals LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (New Vision Pharmaceuticals LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does New Vision Pharmaceuticals LLC have FDA actions?
New Vision Pharmaceuticals LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0853-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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