Drug & Device Safety Atlas

FDA recall record · openFDA

Global Pharma Healthcare Private Limited

5 FDA recalls on record (2023) — 5 drug. 5 still ongoing.

3
Class I (most serious)
2
Class II
0
Class III
5
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Non-Sterility: FDA analysis found unopened products to have bacterial contamination. 2
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in 2
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria. 1

Recalls

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distribut Class I 2023-01-30 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 m Class I 2023-01-30 Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed B Class I 2023-02-24 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distribut Class II 2023-01-30 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 m Class II 2023-01-30

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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