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          Kilitch Healthcare India Limited Issues Amendments in Last Voluntary Nationwide Recall Press ReleaseRecalls, Market Withdrawals, & Safety Alerts COMPANY ANNOUNCEMENT
    
  
  
  Kilitch Healthcare India Limited Issues Amendments in Last Voluntary Nationwide Recall Press Release

  
    
        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:
             January 19, 2024

                          FDA Publish Date: 
               January 22, 2024
                                    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



The firm issued a press release on 11/15/2023. This press release amendment includes corrected NDC numbers for the mentioned products.


FOR IMMEDIATE RELEASE –January 05, 2024– Mumbai, Maharashtra, Kilitch Healthcare India Limited is issuing an amendment in the last Nationwide press release dated November 13, 2023 issued for nationwide recall of various eye drops. There are corrections in product NDC No for the below mentioned products.

Product
			Product Information
			NDC NO
			(wrongly
			Mention is last
			press release)
			NDC Nos
			(Corrected, to
			be read as)
			Retailer /
			LabelLUBRICANT GEL DROPS 15 ML
			Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
			11822-9706-5
			11822-4540-5
			Rite AidLUBRICANT EYE DROPS 15ML (TWIN PACK)
			Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
			11822-9707-5
			11822-4811-5
			Rite Aid

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.

Original Press Release.





Company Contact Information
  
  
    Consumers:       

        
        
                 regulatory@velocitypharma.com or regulatory@kilitchhealthcare.com

                                                                                  Content current as of:
      01/22/2024
               
             
Regulated Product(s)
		 Drugs   
        
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