Elevated risk U.S. Food and Drug Administration

Kilitch Healthcare India Limited Lubricant Eye Drops & Multi-Symptom Eye Drops recall: Device & Drug Safety Potential Safety Concerns

Recall published 2+ years ago Last updated

Device & Drug Safety Potential Safety Concerns

The hazard: Drug safety concern

The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

What the notice says: Device & Drug Safety Potential Safety Concerns

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
November 15, 2023
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Kilitch Healthcare India Limited
Product type
Prescription & OTC drugs
Distribution
Nationwide
Sold at
Rite Aid, Walmart, Target, CVS

Products covered by this recall

Lubricant Eye Drops & Multi-Symptom Eye Drops

What the company announced

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: LUBRICANT GEL DROPS 15 ML · Product Information: Carboxymethylcellulose Sodium Eye Drops 1.0% W/V · NDC NO (wrongly Mention is last press release): 11822-9706-5 · NDC Nos (Corrected, to be read as): 11822-4540-5 · Retailer / Label: Rite Aid
  • Product: LUBRICANT EYE DROPS 15ML (TWIN PACK) · Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V · NDC NO (wrongly Mention is last press release): 11822-9707-5 · NDC Nos (Corrected, to be read as): 11822-4811-5 · Retailer / Label: 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 [email protected] or [email protected] 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.

Original Press Release .

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

How this recall developed

The company posted 2 announcements about this recall on fda.gov. They are kept together on this page: the products, codes and places listed above are combined from all of them, and the announcement text comes from the most recent English version.

  1. November 15, 2023 — First announcement. Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons Read it on fda.gov
  2. January 19, 2024 — Amended announcement. Kilitch Healthcare India Limited Issues Amendments in Last Voluntary Nationwide Recall Press Release Read it on fda.gov

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2023

Package size

Match the net weight or the piece count on the front of the pack.

  • 15 ML
  • 10 ML

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Kilitch Healthcare India Limited — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

  1. Check the lot number on your pack against the codes listed above.
  2. Report side effects you think the product caused to FDA MedWatch.
  3. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  4. Ask the dispensing pharmacy for a replacement from an unaffected lot.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Kilitch Healthcare India Limited — Consumers: [email protected] or [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Kilitch Healthcare India Limited prescription & otc drugs recalled?

Device & Drug Safety Potential Safety Concerns Device & Drug Safety Potential Safety Concerns

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: best-by date 2023. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide, including at Rite Aid, Walmart, Target, CVS.

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