Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution Recalled Due to Defective Container
Micro Labs USA Inc. is recalling one lot of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution nationwide because the container may have broken cap spikes and undeliverable drops.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this recall as Class II, and the source reports no injuries or hospitalizations. The defective container is a risk-of-harm issue where injury has not yet been reported, matching the High rubric criterion.
Plain-English summary
Micro Labs USA Inc. is recalling one lot of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10 mL bottles, Rx only. The affected lot is DLHU0031 with expiration date 06/30/2027, NDC 42571-147-26. The product is manufactured by Micro Labs Limited, India, and manufactured for Micro Labs USA Inc., Somerset, NJ 08873. It was distributed nationwide in the USA.
The recall was initiated because the firm received multiple complaints of broken cap spikes and undeliverable drops, indicating a defective container. The FDA has classified this recall as Class II.
Consumers who have the affected lot should contact their pharmacist or healthcare provider for guidance. Patients should not use product from the affected lot if the container appears damaged or if drops cannot be delivered.
The recalled product
- Product
- DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE)
- Brand
- DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION
- Manufacturer
- MICRO LABS USA INC
- Category
- Drug — Ophthalmic Solution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # DLHU0031
- Exp Date: 06/30/2027.
UPCs (1)
- 0342571147266
Distribution
Distributed nationwide across the United States.
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