MICRO LABS USA INC — Class II: Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx o
Micro Labs USA Inc. has initiated a Class II recall for Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, following reports of defective containers. The firm received multiple complaints regarding broken cap spikes and the inability to deliver drops from the 10mL bottles.
This recall affects Micro Labs USA Inc., its manufacturing partner Micro Labs Limited, and professionals involved in the distribution and quality oversight of ophthalmic solutions.
A Class II recall for container defects suggests a failure in the container-closure system's mechanical integrity, which can lead to dosing inaccuracies or product contamination. For regulatory professionals, this underscores the importance of robust incoming component inspection and the monitoring of physical container performance during post-market surveillance.
Quality units should review container-closure integrity data and component supplier performance for ophthalmic products. Regulatory teams should ensure complaint handling systems are effectively capturing and trending physical device failures, such as cap spikes, to trigger timely corrective actions.
Class II. Reason: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.. Product: Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.. Firm: MICRO LABS USA INC (Somerset NJ United States). Status: Ongoing.
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