FDA Recall D-0921-2023

Global Pharma Healthcare Private Limited · Chennai, N/A

Class I — life-threatening Ongoing 1200 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 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.

Lot / code: Lot #: PCMH001, PCMH002, PCMH005, PCMH007, Exp. date NOV-2023

Quantity: 400,008 bottles total for all products

Reason for recall

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Recall record

Recall number: D-0921-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Product was distributed to two distributors who further distributed Nationwide in the USA.
Recall initiated: 2023-01-30
Classified by FDA Center: 2023-07-14
FDA published: 2023-07-19
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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