CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05...

FDA Drug Recall #D-0296-2024 — Class I — November 13, 2023

Recall Summary

Recall Number D-0296-2024
Classification Class I — Serious risk
Date Initiated November 13, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Kilitch Healthcare India Limited
Location Navi Mumbai
Product Type Drugs
Quantity 253,080 bottles

Product Description

CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15

Reason for Recall

Non-Sterility

Distribution Pattern

Nationwide within the United States

Lot / Code Information

All lots

Other Recalls from Kilitch Healthcare India Limited

Recall # Classification Product Date
D-0311-2024 Class I Up&Up brand dry eye relief (Carboxymethylcellul... Nov 13, 2023
D-0302-2024 Class I Velocity Pharma brand Lubricating Eye Drop (Pro... Nov 13, 2023
D-0290-2024 Class I CVS Health brand Lubricant Eye Drops (Carboxyme... Nov 13, 2023
D-0300-2024 Class I Target brand High Performance Lubricant Eye Dro... Nov 13, 2023
D-0305-2024 Class I CVS Health brand Mild Moderate Lubricating Eye ... Nov 13, 2023

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.