The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0922-2023·Announced 2023-07-19

Artificial Tears Eye Drops Recalled Due to Manufacturing Facility Contamination

Delsam Pharma's artificial tears eye drops are being recalled nationwide due to confirmed contamination linked to manufacturing facility defects. All affected lots were distributed via two distributors.

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 classified this as a Class II recall. Confirmed contamination in eye drops poses a risk of eye infection and injury, even though no illnesses have been reported to date. The manufacturing facility deviations that led to contamination support a High severity rating.

Plain-English summary

Delsam Pharma Llc is recalling all lots of its ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops (10 mg in 1 ml, 1%, 1/2 fl oz/15 ml bottles) due to confirmed contamination. The recall was issued by the FDA as a Class II action after contamination was detected in certain lots manufactured at the same facility under identical conditions.

The recalled product was manufactured by Global Pharma Healthcare Private Limited and distributed nationwide in the USA through two distributors. The affected lot numbers are PCMH003, PCMH004, PCMH006, and PCMH008, all with expiration dates in November 2023. A total of 400,008 bottles have been recalled.

Consumers should discontinue use of the affected product immediately. Anyone who has used these eye drops should consult their healthcare provider if they experience any eye discomfort, irritation, or signs of infection.

The recalled product

Product
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
Manufacturer
Global Pharma Healthcare Private Limited
Category
Drug — Ophthalmic / Lubricant
Hazard
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 (5)

  • Lot #: PCMH003
  • PCMH004
  • PCMH006
  • PCMH008
  • Exp. date NOV-2023

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 →

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