Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (1...

FDA Drug Recall #D-0919-2023 — Class I — January 30, 2023

Recall Summary

Recall Number D-0919-2023
Classification Class I — Serious risk
Date Initiated January 30, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Global Pharma Healthcare Private Limited
Location Chennai, N/A
Product Type Drugs
Quantity 400,008 bottles total for all products

Product Description

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.

Reason for Recall

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Distribution Pattern

Product was distributed to two distributors who further distributed Nationwide in the USA.

Lot / Code Information

Lot #: PCMI005, Exp. date AUG-2024; PCMJ001, PCMJ002, PCMJ004, PCMJ005, PCMJ006, PCMJ008, PCMJ009, PCMJ010, PCMJ011, PCMJ012, PCMJ013, PCMJ014, PCMJ015, Exp. date MAR-2025

Other Recalls from Global Pharma Healthcare Private Limited

Recall # Classification Product Date
D-0488-2023 Class I Delsam Pharma's Artificial Eye Ointment (Minera... Feb 24, 2023
D-0921-2023 Class I Delsam Pharma's ARTIFICIAL TEARS (Carboxymethyl... Jan 30, 2023
D-0920-2023 Class II Artificial Tears (Carboxymethylcellulose Sodium... Jan 30, 2023
D-0922-2023 Class II Delsam Pharma's ARTIFICIAL TEARS (Carboxymethyl... Jan 30, 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.