Drug product
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
D-0373-2022
Product summary
- Event
- Event 89192
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 66,099 dropper bottles; b) 21,243 dropper bottles
- Official record key
drug-enforcement:D-0373-2022
Official wording
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 product not dispensing.
Code information: 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
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
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.