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          Recalls, Market Withdrawals, & Safety Alerts
          Kilitch Healthcare India Limited Issues Voluntary  Nationwide Recall of Various Eye Drops for Potential Safety ReasonsRecalls, Market Withdrawals, & Safety Alerts 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.
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  Company Announcement Date:
             November 15, 2023

                          FDA Publish Date: 
               November 15, 2023
                                    Product Type: 
              Drugs
                          Reason for Announcement:
              Recall Reason Description
              Device & Drug Safety Potential Safety Concerns

            Company Name: 
              Kilitch Healthcare India Limited

            Brand Name:
              Brand Name(s)
          Multiple brands

            Product Description:
              Product Description
          Lubricant 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 / LabelLUBRICATING TEARS EYE DROPS 15 ML
			Dextran 70- 0.1% w/v, Glycerin 0.2% w/v, Hypromellose 0.3% w/v
			0536-1282-94
			RugbyPolyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml
			Polyvinyl alcohol Eye Drops 1.4% w/v
			0536-1325-94
			RugbyHigh Performance Lubricant Eye Drops 15 ml (Single Pack)
			Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
			11673-522-15
			TargetHigh Performance Lubricant Eye Drops 15 ml (Twin Pack)
			Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
			11673-522-30
			TargetMULTI-ACTION RELIEF DROPS 15ML
			Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops
			11822-2254-3
			Rite AidLUBRICATING GEL DROPS 10ML
			Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
			11822-4540-3
			Rite AidLUBRICANT EYE DROPS 10ML (TWIN PACK)
			Propylene glycol Eye Drops 0.6% w/v
			11822-4811-3
			Rite AidLUBRICANT GEL DROPS 15 ML
			Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
			11822-9706-5
			Rite AidLUBRICANT EYE DROPS 15ML (TWIN PACK)
			Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
			11822-9707-5
			Rite AidEye Irritation Relief 15 ml
			Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops
			70000-0087-1
			LeaderDry Eye Relief 10 ml
			Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
			70000-0088-1
			LeaderDry Eye Relief 15 ml
			Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
			70000-0089-1
			LeaderLubricant Eye Drops 15 ML (Single Pack)
			Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
			70000-0090-1
			LeaderLubricant Eye Drops 15 ML (Twin Pack)
			Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
			70000-0090-2
			LeaderLubricant Eye Drops 10 ml
			Propylene glycol Eye Drops 0.6% w/v
			70000-0587-1
			LeaderLUBRICANT EYE DROP 10ML (TRIPLE PACK)
			Propylene glycol Eye Drops 0.6% w/v
			76168-502-30
			VelocityLubricant Eye Drops 15 ML (Single Pack)
			Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
			76168-702-15
			CVSLubricant Eye Drops 15 ML (Twin Pack)
			Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
			76168-702-30
			CVSLubricant Gel Drops 15 ml (Single Pack)
			Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
			76168-704-15
			CVSLubricant Gel Drops 15 ml (Twin Pack)
			Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
			76168-704-30
			CVSMulti Action Relief Drops 15 ml
			Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops
			76168-706-15
			CVSMILD MODERATE LUBRICATING EYE DROPS 15ML
			Polyethylene glycol 400 0.4% w/v
			76168-711-15
			CVSLubricant Gel Drops 10 ml
			Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
			76168-712-10
			CVSLubricant Eye Drops 10 ml (Single Pack)
			Propylene glycol Eye Drops 0.6% w/v
			76168-714-10
			CVSLubricant Eye Drops 10 ml (Twin Pack)
			Propylene glycol Eye Drops 0.6% w/v
			76168-714-20
			CVSDRY EYE RELIEF 15 ML (TWIN PACK)
			Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
			76168-800-30
			TargetEQUATE 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-0178This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Amendments Press Release.





Company Contact Information
  
  
    Consumers:       

        
        
                 regulatory@velocitypharma.com or regulatory@kilitchhealthcare.com

                                                                                  Content current as of:
      11/15/2023
               
             
Regulated Product(s)
		 Drugs   
        
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