FDA Recall D-0922-2023

Global Pharma Healthcare Private Limited · Chennai, N/A

Class II Ongoing 1200 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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 #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023

Quantity: 400,008 bottles total for all products

Reason for recall

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Recall record

Recall number: D-0922-2023
Classification: Class II
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

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

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

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