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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91621

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 30, 2023
Product types
Drug
Classifications
Class I and Class II
Statuses
Ongoing
Recalling firm wording
Global Pharma Healthcare Private Limited

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 4

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.

D-0919-2023
Recall number
D-0919-2023
Initiated
January 30, 2023
Classification
Class I
Status
Ongoing
Quantity
400,008 bottles total for all products

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
bacterial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: PCMI005, Exp. date AUG-2024; PCMJ001, PCMJ002, PCMJ004, PCMJ005, PCMJ006, PCMJ008, PCMJ009, PCMJ010, PCMJ011, PCMJ012, PCMJ013, PCMJ014, PCMJ015, Exp. date MAR-2025

Distribution pattern

Product was distributed to two distributors who further distributed Nationwide in the USA.

drug · product 2 of 4

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.

D-0920-2023
Recall number
D-0920-2023
Initiated
January 30, 2023
Classification
Class II
Status
Ongoing
Quantity
400,008 bottles total for all products

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lot #: PCMH009, PCMH010, PCMH011, PCMH012, PCMH013, PCMH014, PCMH015, PCMH016, exp. date Nov-2023; PCMI001, PCMI002, PCMI003, PCMI004, PCMI006, PCMI 07, PCMI 008, Exp. date AUG-2024; PCMJ003, PCMJ007, PCMJ016, Exp. date MAR-2025

Distribution pattern

Product was distributed to two distributors who further distributed Nationwide in the USA.

drug · product 3 of 4

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.

D-0921-2023
Recall number
D-0921-2023
Initiated
January 30, 2023
Classification
Class I
Status
Ongoing
Quantity
400,008 bottles total for all products

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
bacterial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Product was distributed to two distributors who further distributed Nationwide in the USA.

drug · product 4 of 4

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.

D-0922-2023
Recall number
D-0922-2023
Initiated
January 30, 2023
Classification
Class II
Status
Ongoing
Quantity
400,008 bottles total for all products

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Product was distributed to two distributors who further distributed Nationwide in the USA.