The Recall Desk
CriticalFDA (Drugs)·D-0308-2024·Announced 2024-02-14

FDA Class I Drug Recall: Non-Sterile Multi-Action Relief Drops

Rite Aid is recalling Multi-Action Relief Drops nationwide due to non-sterility concerns. The FDA classified this as a Class I recall affecting 9,216 bottles.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification requires a Critical score; non-sterility in eye drops presents a significant infection risk.

Plain-English summary

Rite Aid is recalling Multi-Action Relief Drops due to non-sterility concerns. The product contains polyvinyl alcohol 0.5%, providone 0.6%, and tetrahydrozoline hydrochloride 0.05%, packaged in 0.5 FL OZ (15 mL) bottles with NDC 11822-2254-3.

The manufacturer, Kilitch Healthcare India Limited, initiated this Class I recall. A total of 9,216 bottles were distributed nationwide throughout the United States in all lot numbers.

Non-sterile eye drops may pose a risk of serious eye infection. Consumers who have purchased this product should stop using it immediately and seek guidance from their healthcare provider or Rite Aid.

The recalled product

Product
Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3
Manufacturer
Kilitch Healthcare India Limited
Category
Drug — Eye Drops
Hazard
  • non-sterility
  • infection-risk

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.

Related recalls

Same category