FDA (Drugs) recall action 93357

Kilitch Healthcare India Limited recalled 22 products on 2024-02-14

The FDA (Drugs) publishes a recall like this one as 22 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 22 pages.

Products: 22
Announced: 2024-02-14
Critical: 6
Units: 3,518,460

Why these products were recalled

Non-Sterility

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–22 of 22

SevereFDA (Drugs)··2024-02-14
CVS Health Lubricant Eye Drops Recalled Due to Non-Sterility
CVS Health brand Lubricant Eye Drops are being recalled due to non-sterility concerns. Kilitch Healthcare India Limited initiated this voluntary recall affecting 386,256 bottles distributed nationwide.
Product
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 028
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CriticalFDA (Drugs)··2024-02-14
FDA Recalls CVS Health Lubricating Eye Drops Due to Non-Sterility
CVS Health brand Lubricating Eye Drops are being recalled due to non-sterility. The FDA Class I recall affects 45,408 bottles distributed nationwide.
Product
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
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SevereFDA (Drugs)··2024-02-14
Drug: Lubricant Eye Drops Recalled Nationwide Due to Non-Sterility
Kilitch Healthcare India Limited is recalling 7,200 bottles of Lubricant Gel Drops distributed nationwide by Rite Aid due to non-sterility concerns. The manufacturer voluntarily initiated the recall.
Product
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
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0 states
SevereFDA (Drugs)··2024-02-14
FDA recalls Leader brand Lubricant Eye Drops nationwide for non-sterility
Leader brand Lubricant Eye Drops (0.6% Propylene glycol) are recalled nationwide due to non-sterility concerns. Consumers should discontinue use immediately.
Product
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
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SevereFDA (Drugs)··2024-02-14
FDA Recalls Non-Sterile Lubricant Eye Drops Due to Contamination Risk
The FDA recalled approximately 210,192 bottles of Leader brand Lubricant Eye Drops due to non-sterility that could allow contamination. All lots distributed nationwide are affected.
Product
LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
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SevereFDA (Drugs)··2024-02-14
Drug recall: Velocity Pharma Lubricating Eye Drops non-sterility risk
Kilitch Healthcare is recalling all lots of Velocity Pharma Lubricating Eye Drop due to non-sterility issues. The product was distributed nationwide; consumers should stop using it immediately.
Product
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
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0 states
SevereFDA (Drugs)··2024-02-14
Drug Recall: Non-Sterile Lubricant Eye Drops Distributed Nationwide
Rite Aid is recalling lubricant eye drops due to non-sterility concerns. All lots of the Carboxymethylcellulose Sodium 0.5% product are affected.
Product
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
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0 states
CriticalFDA (Drugs)··2024-02-14
FDA Class I Drug Recall: Non-Sterile Multi-Action Relief Drops
Rite Aid is recalling Multi-Action Relief Drops nationwide due to non-sterility concerns. The FDA classified this as a Class I recall affecting 9,216 bottles.
Product
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
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0 states
CriticalFDA (Drugs)··2024-02-14
FDA recalls Rugby brand lubricating eye drops nationwide for non-sterility
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops are being recalled nationwide due to non-sterility. The recall affects all lots of the 0.5 FL OZ bottles distributed.
Product
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
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0 states
CriticalFDA (Drugs)··2024-02-14
Drug recall: DRY EYE RELIEF eye drops for non-sterility
FDA recalls DRY EYE RELIEF eye drops nationwide due to non-sterility. The ophthalmic product distributed in 23,208 bottles affects all lots. Consumers should discontinue use immediately.
Product
DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
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0 states
SevereFDA (Drugs)··2024-02-14
Target Lubricant Eye Drops Recalled for Non-Sterility
Target brand High Performance Lubricant Eye Drops have been recalled nationwide due to non-sterility. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary FDA Class I recall affecting 401,568 bottles.
Product
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
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0 states
SevereFDA (Drugs)··2024-02-14
Up&Up Dry Eye Relief Nationwide Recall for Non-Sterility
Up&Up brand dry eye relief (0.5 FL OZ) distributed by Target nationwide is being recalled due to non-sterility. The FDA Class I recall affects all lots of this ophthalmic drug.
Product
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
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0 states
SevereFDA (Drugs)··2024-02-14
CVS Multi Action Relief Drops Recalled for Non-Sterility
CVS brand Multi Action Relief Drops are being recalled nationwide due to non-sterility, which could allow microbial contamination in the product. The voluntary recall covers all lots of the eye drops.
Product
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
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SevereFDA (Drugs)··2024-02-14
CVS Health Lubricating Gel Drops Recalled Due to Non-Sterility
CVS Health brand Lubricating Gel Drops are being recalled due to non-sterility concerns. The voluntary recall affects approximately 110,832 bottles distributed nationwide.
Product
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
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SevereFDA (Drugs)··2024-02-14
FDA Recalls Rugby Lubricating Tears Eye Drops for Non-Sterility
Rugby brand Lubricating Tears Eye Drops have been recalled nationwide for non-sterility. Kilitch Healthcare India Limited initiated the voluntary recall of 56,520 bottles due to potential contamination concerns.
Product
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
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SevereFDA (Drugs)··2024-02-14
Eye Irritation Relief Drops Recalled Nationwide for Non-Sterility
Eye Irritation Relief drops are being recalled nationwide due to non-sterility. The FDA classified this as a Class I recall affecting 10,944 bottles distributed across all production lots.
Product
EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
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SevereFDA (Drugs)··2024-02-14
CVS Health Lubricant Eye Drops Recalled for Non-Sterility
CVS Health brand Lubricant Eye Drops are recalled due to non-sterility. All lots distributed nationwide are affected; consumers should discontinue use.
Product
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.
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0 states
CriticalFDA (Drugs)··2024-02-14
Drug: CVS Health Lubricant Gel Drops recalled nationwide for non-sterility
CVS Health Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) are being recalled nationwide due to non-sterility concerns. All lots of the product in single and twin pack bottles are affected.
Product
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.
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CriticalFDA (Drugs)··2024-02-14
FDA recalls non-sterile EQUATE lubricant eye drops nationwide
Walmart's EQUATE brand Hydration PF Lubricant Eye Drops are being recalled due to non-sterility. This FDA Class I recall affects 33,984 bottles distributed nationwide.
Product
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
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SevereFDA (Drugs)··2024-02-14
FDA Recalls Lubricant Eye Drops Due to Non-Sterility
Rite Aid is recalling all lots of Lubricant Gel Drops due to non-sterility concerns. The product was distributed nationwide.
Product
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
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0 states
SevereFDA (Drugs)··2024-02-14
FDA Recalls Dry Eye Relief Drops Nationwide Due to Non-Sterility
The FDA has issued a Class I recall of Dry Eye Relief eye drops sold nationwide due to non-sterility concerns. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary recall affecting 12,960 bottles.
Product
DRY EYE RELIEF (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL)
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SevereFDA (Drugs)··2024-02-14
Lubricant Eye Drops Recalled Due to Non-Sterility Concerns
Rite Aid is recalling 7,296 bottles of lubricant eye drops nationwide due to non-sterility. The FDA has classified this as a Class I recall.
Product
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
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