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
- Affected units
- 9,216
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.
Part of a larger recall action
This product is one of 22 recalled by Kilitch Healthcare India Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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