The Recall Desk
SevereFDA (Drugs)·D-0306-2024·Announced 2024-02-14

Drug: Lubricant Eye Drops Recalled Nationwide Due to Non-Sterility

Kilitch Healthcare India Limited is recalling 7,200 bottles of Lubricant Gel Drops distributed nationwide by Rite Aid due to non-sterility concerns. The manufacturer voluntarily initiated the recall.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as Class I, which per the rubric requires a minimum severity score of 4. The hazard is non-sterility in an ophthalmic product, a serious concern, though no illnesses have been reported to date.

Plain-English summary

Kilitch Healthcare India Limited is recalling 7,200 bottles of Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%) distributed nationwide by Rite Aid. The product is packaged in 0.5 FL OZ (15 mL) bottles, and all lots are included in the recall (NDC 11822-4540-5).

The recall was voluntarily initiated by the manufacturer because the product is non-sterile. The FDA classified this as a Class I recall, indicating a serious safety concern requiring immediate action.

Consumers who have purchased this product should discontinue use and return it to the retailer for a refund or replacement. Those with health concerns should consult a healthcare provider.

The recalled product

Product
Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5
Manufacturer
Kilitch Healthcare India Limited
Hazard
  • non-sterility

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.