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
Reported: January 26, 2022 Initiated: December 8, 2021 #D-0373-2022
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- a) 66,099 dropper bottles; b) 21,243 dropper bottles
- Distribution
- Nationwide in the USA
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA. Units affected: a) 66,099 dropper bottles; b) 21,243 dropper bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 26, 2022. Severity: Moderate. Recall number: D-0373-2022.
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