CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), ...

FDA Recall #D-0294-2024 — Class I — November 13, 2023

Recall #D-0294-2024 Date: November 13, 2023 Classification: Class I Status: Ongoing

Product Description

CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10

Reason for Recall

Non-Sterility

Recalling Firm

Kilitch Healthcare India Limited — Navi Mumbai

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

110,832 bottles

Distribution

Nationwide within the United States

Code Information

All lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated