Home / Recalls / Global Pharma Healthcare Private Limited / D-0488-2023

D-0488-2023 Class I Ongoing

Recalled by Global Pharma Healthcare Private Limited — Chennai, N/A

Recall Details

Product Type
Drugs
Report Date
March 29, 2023
Initiation Date
February 24, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50,000 tubes

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.

Distribution Pattern

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

Other recalls by Global Pharma Healthcare Private Limited

  • D-0922-2023 Class II — Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye D (January 30, 2023)
  • D-0919-2023 Class I — Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 (January 30, 2023)
  • D-0921-2023 Class I — Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye D (January 30, 2023)
  • D-0920-2023 Class II — Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 (January 30, 2023)