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| The United States: Stokes Healthcare Inc. issues voluntary nationwide recall of Pilocarpine 0.1% Ophthalmic Solution due to a high level of preservative (English Only) |
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The US Food and Drug Administration (FDA) announces that Stokes Healthcare Inc. is voluntarily recalling 1 lot (lot number: R180052; expiration date: February 17, 2019) of 81 units of Pilocarpine 0.1% Ophthalmic Solution, to the consumer and veterinarian office levels. The ophthalmic solution has been found to contain a higher level of the preservative benzalkonium chloride than is typical.
Use of this product potentially could result in irreversible dry eye syndrome due to the elevated concentration of preservative in these eye drops. Dry eye requires lifelong medical intervention and can lead to pain and blindness if left unmanaged. If the pet is displaying excessive blinking, swelling of the eye, eye discharge, or other signs of eye irritation, please contact the veterinarian. Stokes Healthcare has performed an extensive investigation into this event. To date, Stokes Healthcare Inc. has received 8 complaints of eye irritation, a common side effect of pilocarpine ophthalmic solution.
The product was distributed to pet owners and veterinarian offices.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm633445.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Mar 15, 2019
Issued at HKT 16:00
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