COMPANY ANNOUNCEMENT
Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason DescriptionDevice & Drug Safety Potential Safety Concerns
- Company Name:
- Kilitch Healthcare India Limited
- Brand Name:
-
Brand Name(s)Multiple brands
- Product Description:
-
Product DescriptionLubricant Eye Drops & Multi-Symptom Eye Drops
Company Announcement
FOR IMMEDIATE RELEASE –November 13, 2023– Mumbai, Maharashtra, Kilitch Healthcare India Limited is voluntarily recalling the eye drops products listed in the table below 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.
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 potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. To date, Kilitch Healthcare India Limited has not received any reports of adverse events related to this recall.
| Product | Product Information | NDC NO | Retailer / Label |
|---|---|---|---|
| LUBRICATING TEARS EYE DROPS 15 ML | Dextran 70- 0.1% w/v, Glycerin 0.2% w/v, Hypromellose 0.3% w/v | 0536-1282-94 | Rugby |
| Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml | Polyvinyl alcohol Eye Drops 1.4% w/v | 0536-1325-94 | Rugby |
| High Performance Lubricant Eye Drops 15 ml (Single Pack) | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 11673-522-15 | Target |
| High Performance Lubricant Eye Drops 15 ml (Twin Pack) | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 11673-522-30 | Target |
| MULTI-ACTION RELIEF DROPS 15ML | Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops | 11822-2254-3 | Rite Aid |
| LUBRICATING GEL DROPS 10ML | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 11822-4540-3 | Rite Aid |
| LUBRICANT EYE DROPS 10ML (TWIN PACK) | Propylene glycol Eye Drops 0.6% w/v | 11822-4811-3 | Rite Aid |
| LUBRICANT GEL DROPS 15 ML | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 11822-9706-5 | Rite Aid |
| LUBRICANT EYE DROPS 15ML (TWIN PACK) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 11822-9707-5 | Rite Aid |
| Eye Irritation Relief 15 ml | Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops | 70000-0087-1 | Leader |
| Dry Eye Relief 10 ml | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 70000-0088-1 | Leader |
| Dry Eye Relief 15 ml | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 70000-0089-1 | Leader |
| Lubricant Eye Drops 15 ML (Single Pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 70000-0090-1 | Leader |
| Lubricant Eye Drops 15 ML (Twin Pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 70000-0090-2 | Leader |
| Lubricant Eye Drops 10 ml | Propylene glycol Eye Drops 0.6% w/v | 70000-0587-1 | Leader |
| LUBRICANT EYE DROP 10ML (TRIPLE PACK) | Propylene glycol Eye Drops 0.6% w/v | 76168-502-30 | Velocity |
| Lubricant Eye Drops 15 ML (Single Pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 76168-702-15 | CVS |
| Lubricant Eye Drops 15 ML (Twin Pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 76168-702-30 | CVS |
| Lubricant Gel Drops 15 ml (Single Pack) | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 76168-704-15 | CVS |
| Lubricant Gel Drops 15 ml (Twin Pack) | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 76168-704-30 | CVS |
| Multi Action Relief Drops 15 ml | Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops | 76168-706-15 | CVS |
| MILD MODERATE LUBRICATING EYE DROPS 15ML | Polyethylene glycol 400 0.4% w/v | 76168-711-15 | CVS |
| Lubricant Gel Drops 10 ml | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 76168-712-10 | CVS |
| Lubricant Eye Drops 10 ml (Single Pack) | Propylene glycol Eye Drops 0.6% w/v | 76168-714-10 | CVS |
| Lubricant Eye Drops 10 ml (Twin Pack) | Propylene glycol Eye Drops 0.6% w/v | 76168-714-20 | CVS |
| DRY EYE RELIEF 15 ML (TWIN PACK) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 76168-800-30 | Target |
| EQUATE HYDRATION PF LUBRICANT EYE DROPS 10ML | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 79903-168-01 | Walmart |
These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC.
Kilitch Healthcare India Limited, is notifying its distributor Velocity Pharma LLC and its distributor Velocity Pharma LLC shall be further notifying the wholesalers and retailers via mail of this voluntary recall and is arranging for return of all impacted products listed above. Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled eye drops and may return any of the above listed products to the place of purchase.
Consumers with questions regarding this recall can contact regulatory@velocitypharma.com or regulatory@kilitchhealthcare.com
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.