1 week ago
Nearly 40,000 Eye-Drop Bottles Recalled Over Sterility Concerns
Nearly 40,000 bottles of Clear Eyes eye drops are being recalled in the United States.
The drops are meant to help with itchy and red eyes.
The FDA said there was not enough assurance that the bottles were sterile.
This means the drops might possibly contain germs, although the report did not say contamination was confirmed.
The recalled bottles are 15 mL in size and expire on September 30, 2027.
People should stop using them and ask the store where they bought them about returning them.
The FDA called this a Class II recall, meaning serious harm is considered unlikely and possible effects may be temporary or treatable.
In a separate action, Sun Pharma Distributors Ltd withdrew 10 eye-drop products in India because of contamination concerns.
The US FDA reported a voluntary recall of 39,060 Clear Eyes Maximum Itchy Eye Relief bottles.
The recalled 15 mL bottles have lot code 2552A and expire on September 30, 2027.
The products were distributed nationwide and may pose a potential contamination or infection risk.
The FDA classified the recall as Class II, involving potentially temporary or medically reversible health consequences.
Separately, Sun Pharma Distributors Ltd withdrew 10 eye-drop products in India as a precautionary measure.
- Who
- The US Food and Drug Administration and Prestige Brand Holdings are involved in the US recall; Sun Pharma Distributors Ltd is involved in the separate India withdrawal.
- What
- 39,060 Clear Eyes Maximum Itchy Eye Relief bottles were recalled in the United States, while 10 Sun Pharma eye-drop products were withdrawn in India.
- Where
- The Clear Eyes products were distributed nationwide in the United States; the separate Sun Pharma withdrawal concerned stocks held by distributors in India.
- When
- The US products expire on September 30, 2027; Sun Pharma's distributor letter was issued on July 17, with no year specified in the article.
- Why
- The US recall cited a lack of assurance of sterility and potential contamination; Sun Pharma cited contamination concerns as a precaution.
Key facts
- US product
- Clear Eyes Maximum Itchy Eye Relief
- Quantity recalled
- 39,060 bottles
- Bottle size
- 15 mL, or 0.5 fluid ounces
- Lot code
- 2552A
- Expiration date
- September 30, 2027
- US recall classification
- Class II
- Separate India action
- Sun Pharma Distributors Ltd withdrew 10 eye-drop products and asked distributors to stop billing and return available stock.
Sources
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