Reported Jan 26, 2022 · Terminated

Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml…

Teva Pharmaceuticals USA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teva Pharmaceuticals USA · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120

Is this the product you have?

  • 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 ByIndoco Remedies Limited Verna, Goa - 403722, India
  • Manufactured ForTeva Pharmaceuticals USA, Inc. Parsippany, NJ
Lot codes and dates

5 of 5 products

Products covered by this recall
#Product as published
1BCB1LB2, BCB2LB2, BCB7LB2, Exp. 11/2022
2Lots: BCB11AC2, BCB12AC2, BCB3AC2, BCB4AC2, BCB5AC2, BCB6AC2, BCB10AC2, Exp. 12/2022
3Lots: BCB4LB2, BCB5LB2, Exp. 11/2022
4Lots: BCB1AC2, BCB2AC2, Exp. 12/2022
5Lots: BCB1DC2, BCB2DC2, Exp. 03/2023
Amount recalled
a) 66,099 dropper bottles; b) 21,243 dropper bottles

Where it was sold

  • Nationwide

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 1, 2023 · Data as of Sep 19, 5:07 PM UTC

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