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D-0853-2021 Class III Terminated

Recalled by New Vision Pharmaceuticals LLC — Tamarac, FL

FDA drug recall D-0853-2021 was initiated by New Vision Pharmaceuticals LLC on Sep 2, 2021 and is designated Class III. Reason for recall: Subpotent Drug The recall status is terminated (terminated Jun 21, 2023). Affected quantity: 18,864 FG cartons.

Recall Details

Product Type: Drugs
Report Date: Oct 6, 2021
Initiation Date: Sep 2, 2021
Termination Date: Jun 21, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 18,864 FG cartons

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

Reason for Recall

Subpotent Drug

Distribution Pattern

AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VA

Code Information

Lots: 2021-10154 Exp. 06/29/2023; 2021-10164 Exp. 06/11/2023

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0853-2021
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.