Agency classClass IIOur severity:High FDA (Drugs)·D-0920-2023·Announced 2023-07-19

EzriCare Artificial Tears Eye Drops Recalled for Manufacturing Contamination

EzriCare Artificial Tears eye drops are being recalled nationwide due to manufacturing facility contamination and CGMP deviations. The recall includes multiple lot numbers distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for manufacturing contamination detected in related product lots. Ophthalmic products applied directly to eyes represent a high-risk application where contamination poses significant potential for harm, even though no illnesses have been reported to date.

Plain-English summary

EzriCare, LLC is recalling all distributed Artificial Tears Lubricant Eye Drops (10 MG Carboxymethylcellulose Sodium in 15 ml bottles, NDC 79503-0101-15) manufactured by Global Pharma Healthcare Private Limited. The recall affects approximately 400,008 bottles distributed nationwide through two major distributors.

The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations identified at the manufacturing facility. Some lots were found to be contaminated, and because all lots were manufactured in the same facility under the same conditions, the company is recalling all related lots as a precautionary measure.

Affected lot numbers include PCMH009-016 (expiration Nov 2023), PCMI001-008 (expiration Aug 2024), and PCMJ003/007/016 (expiration Mar 2025).

Consumers using these eye drops should stop use and consult a healthcare provider if they experience any unusual symptoms or eye irritation. Patients may return the product to their pharmacy or contact EzriCare for further instructions.

The recalled product

Product: 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.
Manufacturer: Global Pharma Healthcare Private Limited
Category: Drug — Ophthalmic / Eye Drops
Hazard: contamination
Affected units: 400,008

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot #: PCMH009
PCMH010
PCMH011
PCMH012
PCMH013
PCMH014
PCMH015
PCMH016
exp. date Nov-2023
PCMI001
PCMI002
PCMI003
PCMI004
PCMI006
PCMI 07
PCMI 008
Exp. date AUG-2024
PCMJ003
PCMJ007
PCMJ016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Global Pharma Healthcare Private Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Global Pharma Healthcare Private Limited

See all →

Severe
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FDA (Drugs) · 2023-07-19
Critical
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High
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Severe
Delsam Pharma Artificial Eye Ointment Recalled for Bacterial Contamination
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Same hazard · contamination