CLASS II ONGOING Drug recall · Reported 19 Jul 2023 · FDA Enforcement Report
Delsam Pharma's Artificial Tears recalled by Global Pharma Healthcare
Global Pharma Healthcare Private is recalling Delsam Pharma's Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10, distributed nationwide in the US. The recall was initiated on 30 Jan 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0922-2023
- FDA event ID
- 91621
- Recalling firm
- Global Pharma Healthcare Private, Chennai, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jan 2023
- FDA classified
- 14 Jul 2023
- Reported
- 19 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Eye Drops
Timeline
| 30 Jan 2023 | Recall initiated by company | |
| 14 Jul 2023 | Classified by FDA | +165 days |
| 19 Jul 2023 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Product was distributed to two distributors who further distributed Nationwide in the USA.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023
Where was it sold?
Product was distributed to two distributors who further distributed Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 91621This product is part of a recall event; the main page for the event is Artificial Tears (Carboxymethylcellulose Sodium) Lubricant recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Artificial Tears (Carboxymethylcellulose Sodium) Lubricant recalled | Global Pharma Healthcare Private | Sterility | Nationwide | |
| CLASS I | Delsam Pharma's Artificial Tears recalled by Global Pharma Healthcare | Global Pharma Healthcare Private | Sterility | Nationwide | |
| CLASS II | Artificial Tears (Carboxymethylcellulose Sodium) Lubricant recalled | Global Pharma Healthcare Private | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Global Pharma Healthcare Private
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Artificial Tears (Carboxymethylcellulose Sodium) Lubricant recalled | Global Pharma Healthcare Private | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Delsam Pharma's Artificial Tears recalled by Global Pharma Healthcare | Global Pharma Healthcare Private | Sterility | Nationwide |
| Drug | CLASS I | Artificial Tears (Carboxymethylcellulose Sodium) Lubricant recalled | Global Pharma Healthcare Private | Sterility | Nationwide |
| Drug | CLASS I | Delsam Pharma's Artificial Eye Ointment (Mineral Oil recalled | Global Pharma Healthcare Private | Sterility | Nationwide |