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.
USDorzolamide 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.
Recalling Firm: MICRO LABS USA INC
Reason for Recall / Hazard
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Somerset |
| State | NJ |
| Openfda › Upc | 0342571147266 |
| Openfda › Unii › 1 | QZO5366EW7 |
| Openfda › Unii › 2 | P8Y54F701R |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 1923432 |
| Openfda › Spl id | 22ff7483-50ec-42c6-e063-6394a90ae1fa |
| Openfda › Brand name | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION |
| Openfda › Spl set id | f45cce05-fb47-4607-b68e-5a3d47e7235a |
| Openfda › Package ndc | 42571-147-26 |
| Openfda › Product ndc | 42571-147 |
| Openfda › Generic name | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name › 1 | DORZOLAMIDE HYDROCHLORIDE |
| Openfda › Substance name › 2 | TIMOLOL MALEATE |
| Openfda › Manufacturer name | Micro Labs Limited |
| Openfda › Application number | ANDA204777 |
| Openfda › Is original packager | true |
| Event id | 99481 |
| Address 1 | 220 Davidson Ave |
| Address 2 | N/A |
| Code info | Lot # DLHU0031, Exp Date: 06/30/2027. |
| Postal code | 08873-4149 |
| Report date | 20260805 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260722 |
| Initial firm notification | Letter |
| Center classification date | 20260724 |
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Overview
- Recalling FirmMICRO LABS USA INC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA.
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🚨 SAFETY ALERT: 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, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26. Check if your household is affected: https://therecallfile.com/recalls/dorzolamide-hcl-and-timolol-maleate-ophthalmic-solution-usp-2-0-5-10ml/FDA-D-0730-2026
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