FDA-Drug2022-01-26Class II
Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ
Teva Pharmaceuticals USA
Hazard
Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Sold states
Nationwide in the USA
Affected count
a) 66,099 dropper bottles; b) 21,243 dropper bottles
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0373-2022Don't want to check this manually?
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