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.
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
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 / Label |
|---|---|---|---|---|
| LUBRICANT GEL DROPS 15 ML | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 11822-9706-5 | 11822-4540-5 | Rite Aid |
| LUBRICANT 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-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.