FDA Recall D-0488-2023

Global Pharma Healthcare Private Limited · Chennai, N/A

Class I — life-threatening Ongoing 1175 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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.

Lot / code: Batch # H29, Exp. Date 11/30/2023

Quantity: 50,000 tubes

Reason for recall

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

Recall record

Recall number: D-0488-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
Recall initiated: 2023-02-24
Classified by FDA Center: 2023-03-30
FDA published: 2023-03-29
Recalling firm: Global Pharma Healthcare Private Limited
Firm location: Chennai, N/A, India

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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