Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ...

FDA Recall #D-0307-2024 — Class I — November 13, 2023

Recall #D-0307-2024 Date: November 13, 2023 Classification: Class I Status: Ongoing

Product Description

Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3

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

7,776 bottles

Distribution

Nationwide within the United States

Code Information

All lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated