Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 o...

FDA Recall #D-0488-2023 — Class I — February 24, 2023

Recall #D-0488-2023 Date: February 24, 2023 Classification: Class I Status: Ongoing

Product Description

Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.

Reason for Recall

Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

Recalling Firm

Global Pharma Healthcare Private Limited — Chennai, N/A

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

50,000 tubes

Distribution

Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.

Code Information

Batch # H29, Exp. Date 11/30/2023

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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