Class II Recall

MICRO LABS USA INC

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.
Reason
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Classification
Class II
Status
Ongoing
Lot
Lot # DLHU0031, Exp Date: 06/30/2027.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.