Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper
Summary
The FDA issued a Class II for Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles by Teva Pharmaceuticals USA. Reason: 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 pro.
Details
Source
Drug Recall
External ID
D-0373-2022
Action Date
2022-01-26
Status
Terminated
Category
drug
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
Lot/Code Info: Lots: a)BCB1LB2, BCB2LB2, BCB7LB2, Exp. 11/2022; Lots: BCB11AC2, BCB12AC2, BCB3AC2, BCB4AC2, BCB5AC2, BCB6AC2, BCB10AC2, Exp. 12/2022; b) Lots: BCB4LB2, BCB5LB2, Exp. 11/2022; Lots: BCB1AC2, BCB2AC2, Exp. 12/2022; Lots: BCB1DC2, BCB2DC2, Exp. 03/2023
Quantity Affected: a) 66,099 dropper bottles; b) 21,243 dropper bottles
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.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-08
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Teva Pharmaceuticals USA has 38 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA have FDA actions?
Teva Pharmaceuticals USA has 38 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0373-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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