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.
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 numbers, UPCs & expiration codes
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
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0373-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 8, 2021
- FDA report date
- Jan 26, 2022
- Quantity
- a) 66,099 dropper bottles; b) 21,243 dropper bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0373-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89192
- Address
- 400 Interpace Pkwy
- 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
- Postal code
- 07054-1120
- Report date
- Jan 26, 2022
- Product type
- Drugs
- Recall number
- D-0373-2022
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- a) 66,099 dropper bottles; b) 21,243 dropper bottles
- Termination date
- Jun 1, 2023
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 8, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 14, 2022