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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93357

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

Open FDA event record

Event summary

Timeline bucket
November 13, 2023
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Kilitch Healthcare India 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

22 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 22

CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.

D-0290-2024
Recall number
D-0290-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
386,256 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 2 of 22

Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017

D-0291-2024
Recall number
D-0291-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
210,192 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 3 of 22

CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.

D-0292-2024
Recall number
D-0292-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
137,784 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 4 of 22

Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94

D-0293-2024
Recall number
D-0293-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
1,492,344 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 5 of 22

CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10

D-0294-2024
Recall number
D-0294-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
110,832 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 6 of 22

Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1

D-0295-2024
Recall number
D-0295-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
12,960 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 7 of 22

CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15

D-0296-2024
Recall number
D-0296-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
253,080 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 8 of 22

Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1

D-0297-2024
Recall number
D-0297-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
10,944 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 9 of 22

CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.

D-0298-2024
Recall number
D-0298-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
150,720 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 10 of 22

Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0089-1

D-0299-2024
Recall number
D-0299-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
23,208 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 11 of 22

Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403

D-0300-2024
Recall number
D-0300-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
401,568 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 12 of 22

Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1

D-0301-2024
Recall number
D-0301-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
14,784 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 13 of 22

Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30

D-0302-2024
Recall number
D-0302-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
2,820 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 14 of 22

EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01

D-0303-2024
Recall number
D-0303-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
33,984 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 15 of 22

LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5

D-0304-2024
Recall number
D-0304-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
6,024 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 16 of 22

CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15

D-0305-2024
Recall number
D-0305-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
45,408 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 17 of 22

Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5

D-0306-2024
Recall number
D-0306-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
7,200 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 18 of 22

Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3

D-0307-2024
Recall number
D-0307-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
7,776 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 19 of 22

Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3

D-0308-2024
Recall number
D-0308-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
9,216 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 20 of 22

Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid

D-0309-2024
Recall number
D-0309-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
7,296 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 21 of 22

Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94

D-0310-2024
Recall number
D-0310-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
56,520 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States

drug · product 22 of 22

Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30

D-0311-2024
Recall number
D-0311-2024
Initiated
November 13, 2023
Classification
Class I
Status
Ongoing
Quantity
137,544 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

All lots

Distribution pattern

Nationwide within the United States