Safety Report: Kilitch Healthcare India Limited Lubricant Eye Drops & Multi-Symptom Eye Drops - recalled due to insanitary conditions, USA

United States

Kilitch Healthcare India Limited is voluntarily recalling the eye drops products to the consumer level with all lots within expiry with expiration dates ranging from November, 2023 to September, 2025 for all the below mentioned products. These products are being recalled due to potential safety concerns after FDA investigators found insanitary conditions. These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC. To date, Kilitch Healthcare India Limited has not received any reports of adverse events related to this recall.

Risk Statement: For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potentially heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.

Affected products:

- Product: LUBRICATING TEARS EYE DROPS 15 ML. Product Information: Dextran 70- 0.1% w/v, Glycerin 0.2% w/v, Hypromellose 0.3% w/v. NDC NO: 0536-1282-94. Retailer / Label: Rugby.
- Product: Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml. Product Information: Polyvinyl alcohol Eye Drops 1.4% w/v. NDC NO: 0536-1325-94. Retailer / Label: Rugby.
- Product: High Performance Lubricant Eye Drops 15 ml (Single Pack). Product Information: Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops. NDC NO: 11673-522-15. Retailer / Label: Target.
- Product: High Performance Lubricant Eye Drops 15 ml (Twin Pack). Product Information: Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops. NDC NO: 11673-522-30. Retailer / Label: Target.
- Product: MULTI-ACTION RELIEF DROPS 15ML. Product Information: Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops. NDC NO: 11822-2254-3. Retailer / Label: Rite Aid.
- Product: LUBRICATING GEL DROPS 10ML. Product Information: Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops. NDC NO: 11822-4540-3. Retailer / Label: Rite Aid.
- Product: LUBRICANT EYE DROPS 10ML (TWIN PACK). Product Information: Propylene glycol Eye Drops 0.6% w/v. NDC NO: 11822-4811-3. Retailer / Label: Rite Aid.
- Product: LUBRICANT GEL DROPS 15 ML. Product Information: Carboxymethylcellulose Sodium Eye Drops 1.0% W/V. NDC NO: 11822-9706-5. Retailer / Label: Rite Aid.
- Product: LUBRICANT EYE DROPS 15ML (TWIN PACK). Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V. NDC NO: 11822-9707-5. Retailer / Label: Rite Aid.
- Product: Eye Irritation Relief 15 ml. Product Information: Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops. NDC NO: 70000-0087-1. Retailer / Label: Leader.
- Product: Dry Eye Relief 10 ml. Product Information: Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops. NDC NO: 70000-0088-1. Retailer / Label: Leader.
- Product: Dry Eye Relief 15 ml. Product Information: Carboxymethylcellulose Sodium Eye Drops 1.0% W/V. NDC NO: 70000-0089-1. Retailer / Label: Leader.
- Product: Lubricant Eye Drops 15 ML (Single Pack). Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V. NDC NO: 70000-0090-1. Retailer / Label: Leader.
- Product: Lubricant Eye Drops 15 ML (Twin Pack). Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V. NDC NO: 70000-0090-2. Retailer / Label: Leader.
- Product: Lubricant Eye Drops 10 ml. Product Information: Propylene glycol Eye Drops 0.6% w/v. NDC NO: 70000-0587-1. Retailer / Label: Leader.
- Product: LUBRICANT EYE DROP 10ML (TRIPLE PACK). Product Information: Propylene glycol Eye Drops 0.6% w/v. NDC NO: 76168-502-30. Retailer / Label: Velocity.
- Product: Lubricant Eye Drops 15 ML (Single Pack). Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V. NDC NO: 76168-702-15. Retailer / Label: CVS.
- Product: Lubricant Eye Drops 15 ML (Twin Pack). Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V. NDC NO: 76168-702-30. Retailer / Label: CVS.
- Product: Lubricant Gel Drops 15 ml (Single Pack). Product Information: Carboxymethylcellulose Sodium Eye Drops 1.0% W/V. NDC NO: 76168-704-15. Retailer / Label: CVS.
- Product: Lubricant Gel Drops 15 ml (Twin Pack). Product Information: Carboxymethylcellulose Sodium Eye Drops 1.0% W/V. NDC NO: 76168-704-30. Retailer / Label: CVS.
- Product: Multi Action Relief Drops 15 ml. Product Information: Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops. NDC NO: 76168-706-15. Retailer / Label: CVS.
- Product: MILD MODERATE LUBRICATING EYE DROPS 15ML. Product Information: Polyethylene glycol 400 0.4% w/v. NDC NO: 76168-711-15. Retailer / Label: CVS.
- Product: Lubricant Gel Drops 10 ml. Product Information: Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops. NDC NO: 76168-712-10. Retailer / Label: CVS.
- Product: Lubricant Eye Drops 10 ml (Single Pack). Product Information: Propylene glycol Eye Drops 0.6% w/v. NDC NO: 76168-714-10. Retailer / Label: CVS.
- Product: Lubricant Eye Drops 10 ml (Twin Pack). Product Information: Propylene glycol Eye Drops 0.6% w/v. NDC NO: 76168-714-20. Retailer / Label: CVS.
- Product: DRY EYE RELIEF 15 ML (TWIN PACK). Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V. NDC NO: 76168-800-30. Retailer / Label: Target.
- Product: EQUATE HYDRATION PF LUBRICANT EYE DROPS 10ML. Product Information: Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops. NDC NO: 79903-168-01. Retailer / Label: Walmart.

Consumers, distributors, and retailers that have any product that is being recalled should cease distribution of the product. Consumers should stop using the recalled eye drops and may return any of the products to the place of purchase.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Kilitch Healthcare India Limited
Brand name: Multiple brands
Product recalled: Lubricant Eye Drops & Multi-Symptom Eye Drops
Reason of the recall: Device & Drug Safety Potential Safety Concerns
FDA Recall date: November 15, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kilitch-healthcare-india-limited-issues-voluntary-nationwide-recall-various-eye-drops-potential