February 2023 FDA Recall Drug by Global Pharma Healthcare Private Limited
D-0488-2023 - Non-Sterility

This Class I drug recall was voluntarily initiated by Global Pharma Healthcare Private Limited on February 24, 2023 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0488-2023

Reason for Recall
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Initiated
02-24-2023
Reported
03-29-2023
Quantity
50,000 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91768
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Global Pharma Healthcare Private Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

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