CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bo...

FDA Recall #D-0292-2024 — Class I — November 13, 2023

Recall #D-0292-2024 Date: November 13, 2023 Classification: Class I Status: Ongoing

Product Description

CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.

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

137,784 bottles

Distribution

Nationwide within the United States

Code Information

All lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated