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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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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