Multi-event September 2021 FDA Recall Drug by New Vision Pharmaceuticals Llc

This Multi-event Class III drug recall was voluntarily initiated by New Vision Pharmaceuticals Llc on September 2, 2021 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VA and the recall is currently terminated.

Reported Recall Events

D-0852-2021 TERMINATED D-0853-2021 TERMINATED

Recall Number: D-0852-2021

Reason for Recall
Subpotent Drug
Initiated
09-02-2021
Reported
10-06-2021
Quantity
14,976 FG cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88608
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
New Vision Pharmaceuticals LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Lot# Lot: 2021-10159 Exp. 06/08/2023

Recall Number: D-0853-2021

Reason for Recall
Subpotent Drug
Initiated
09-02-2021
Reported
10-06-2021
Quantity
18,864 FG cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88608
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
New Vision Pharmaceuticals LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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