FDA recall D-0852-2021

New Vision Pharmaceuticals LLC · Class III · drug

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

Reason for recall

Subpotent Drug

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-09-02
Report date
2021-10-06
Termination date
2023-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tamarac, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0852-2021