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MICRO LABS USA INC: Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, M

DrugsSource: FDA (drug) · Date: 2026-08-05

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA.
Recall initiated
2026-07-22
Code info
Lot # DLHU0031, Exp Date: 06/30/2027.
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Somerset
State
NJ
Country
United States
Event id
99481
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